It's important when meeting with your medical team, who helps determine if DBS can help you, to discuss if you ARE a good candidate, and as we will see in the FAQ tab to follow, who is NOT a good candidate. These are conversations you will have with your medical team, and if you are not happy with your current medical team's responses, or lack of, then you as a self-advocate have the right to find a team that aligns with your desires. But, be cautious to understand where your knowledge ends and understand where your medical team's understanding and experience begins. When you work with a medical team, you officially become part of their team and their team joins with you for a best practice for you condition, disorder, or disease state's treatment. What does it mean to be a DBS candidate? Being a DBS candidate means that your medical specialist team believes that deep brain stimulation may reasonably help your symptoms, and that the benefits are likely to outweigh the risks for your specific situation.¹,² DBS is not a cure, and it does not stop disease progression, but it can reduce certain symptoms for well selected people.²,³ Most DBS programs decide candidacy through a structured and multidisciplinary team evaluation, which often includes a neurologist (often a movement disorder specialist), a neurosurgeon, and frequently a neuropsychologist and psychiatrist or psychologist.¹,⁴ Which conditions may qualify for DBS in the United States? In the United States, DBS is typically an FDA approved, or authorized (depending on indication), therapeutic treatment for specific conditions.²,⁵,⁶ We've seen this in previous FAQ tabs, but always bears repeating. Common FDA indications include: • Parkinson’s disease (for certain medication responsive symptoms and complications).⁵ • Essential tremor and Parkinsonian tremor (for disabling tremor not adequately controlled by medication).⁶,⁷ • Epilepsy, specifically drug resistant focal (partial onset) seizures meeting FDA labeled criteria for anterior nucleus of the thalamus stimulation.⁸ • Primary dystonia (under a Humanitarian Device Exemption, HDE).⁹ • Severe, chronic, treatment resistant obsessive compulsive disorder (under an HDE).¹⁰ On International level, the availability, labeling, and candidacy standards can differ by country, health system, and device approvals, even when the procedure is offered.⁴,¹¹ What symptoms make DBS more likely to help in Parkinson’s disease? DBS for Parkinson’s disease is usually considered when symptoms improve with levodopa but medicines no longer provide steady control, or when side effects become limiting. This can look like: • Clear “on” and “off” fluctuations, meaning medication helps, then wears off before the next dose.²,⁵ • Dyskinesia, meaning extra, involuntary movements that can happen when medication levels are high.²,⁵ • Tremor that remains very disabling despite medication.²,³ Many medical teams and centers use this formal “on/off” testing and medication responsiveness as part of selection, because levodopa responsiveness can help predict which motor symptoms are likely to respond to DBS.¹²,¹³ What makes someone more likely to be a candidate for essential tremor DBS? DBS is typically considered when tremor causes meaningful daily disability, and when tremor remains inadequately controlled after appropriate medication trials.⁷,¹⁴ This is often described as “medication refractory” tremor.⁷,¹⁴ A careful diagnosis matters because essential tremor can be confused with other tremor types, and the best treatment plan depends on getting the label right.¹⁴,¹⁵ What about dystonia, epilepsy, and OCD, do the candidate rules differ? Yes, they differ because the goals and evidence base differ. • Dystonia (primary dystonia): FDA HDE labeling specifies chronic, intractable, drug refractory primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia, in patients age 7 or older.⁹ • Epilepsy (anterior nucleus of the thalamus DBS): FDA labeling includes adults 18 or older with epilepsy characterized by partial onset seizures, refractory to three or more antiseizure medications, and meeting specific seizure frequency criteria in labeling.⁸ • OCD (HDE): FDA HDE labeling describes adjunctive DBS for chronic, severe, treatment resistant OCD in adults who have failed multiple medication trials, including at least three SSRIs, and considers DBS as an alternative to anterior capsulotomy in that context.¹⁰ What does “FDA approval” vs “HDE” mean, and why does it matter for candidacy? An HDE, or Humanitarian Device Exemption, is an FDA pathway for devices intended for rare conditions, and it's typically exempt from usual effectiveness requirements.¹⁶,¹⁷ This means that the evidence standard is different than full FDA approval, and some facilities require additional oversight.¹⁶,¹⁸ For example, FDA guidance notes that after HDE approval, use generally occurs in facilities with IRB oversight, with limited exceptions such as emergency use.¹⁸ Who may not be a good candidate, or may need to pause and stabilize first? Candidacy is individualized, but many programs become more cautious when there is: • Significant dementia or major untreated cognitive decline, because thinking and daily function may worsen after surgery or adjustment may be harder.¹,¹⁹ • Uncontrolled or severe depression, mania, psychosis, or active substance use disorder, because surgery and long term device management can add stress and symptoms can affect safety and outcomes.¹,¹⁹ • A diagnosis that is uncertain or suggests an atypical parkinsonism, because response to DBS may be limited when symptoms are not levodopa responsive Parkinson’s disease.¹²,¹³,¹⁹ • Major medical instability that raises surgical risk (for example, uncontrolled bleeding risk, serious cardiopulmonary disease), which your surgical team will evaluate during medical clearance.¹,² Sometimes “not a candidate today” really means “not yet,” because treating sleep, mood, medications, or diagnosis clarity can change the picture.¹,⁴ What tests and visits are usually part of a DBS candidacy workup? Many medical teams and centers use a "stepwise" workup that can include: • Neurology evaluation to confirm diagnosis, symptom pattern, and prior treatment trials.¹,² • Neurosurgery evaluation to review surgical options and risks.¹,² • Brain imaging/brain mapping, often MRI, to plan trajectories and check for findings that could raise risk.¹,² • Neuropsychological testing, which looks at memory, attention, language, mood, and problem solving, to help predict adaptation and risk.¹,¹⁹ • Medication “on/off” testing in Parkinson’s disease to measure how symptoms change with medication, and to support realistic expectations.¹²,¹³ • Discussion in a multidisciplinary conference, because team based selection is commonly recommended.⁴,¹¹ Do age and disease duration matter? Age and duration can matter, but they are rarely the only deciding factor. Many medical teams focus more on your symptom pattern, their diagnosis confidence, the results of the cognitive and psychiatric tests, and overall medical fitness to undergo the surgery.¹,²,¹³ Specific to Parkinson’s disease, the FDA labeling includes levodopa responsive of at least 4 years’ duration in the indication statement for Medtronic Percept specific DBS therapy labeling.⁵ This is primarly because the Medronic Percept DBS system is currently (2025) FDA approved for adaptive programming. What does “realistic expectations” mean in DBS candidacy? It means accurately matching the treatment to what DBS is most likely to improve, and naming what it is unlikely to change. Even though DBS is adjustable, and can reduce certain symptoms, it's not guaranteed to help every symptom of every potentially treatable condition, disorder, or disease state.²,³ Your team shoulod talk with you about a realistic set of goals, like steadier “on” time, less severe tremor, fewer medication side effects, and better daily function and quality of life. Then they should compare those goals to what DBS typically addresses for your condition.¹,² What if my diagnosis is not on the FDA approved list, can I still be evaluated? Possibly, but it often becomes a conversation more about research or investigational use rather than treatment option. Since DBS is currently being studied for several neurological and psychiatric conditions beyond the main FDA indications, usually in clinical trials or specialized programs, until there is verifiable results from studies, it doesn't even have a chance to be considered for FDA approval.² Remember that just because you are not in the United States, as many of you reading this may be, your region and country may have different standards for non-movement disorder therapy with DBS! Now, if you are exploring an investigational indication, here are some questions to ask your medical team: • Is this offered only in a clinical trial at your medical center? • What outcomes do you use for measuring, and what does that timeline look like? • What are some alternatives that may work for me, including non surgical options?²,¹¹ What questions should I bring to a DBS candidacy appointment? These questions can help you have better conversations with your medical team, and enable you to guide the conversation: • What diagnosises are you currently treating, and how confident are you in using DBS to treat that condition?¹,² • Which symptoms do you, as my doctor, expect DBS to help me with the most, and which are least likely to change?²,³ • What target in my brain would you consider (for example STN, GPi, VIM, ANT) for my specific treatment, and why is it best for my symptoms?² • What testing do you require before deciding to do DBS for me specifically, and what test results could rule me out as a good candidate?¹,² • What are the most common risks you have experienced in doing DBS surgery, and what have you done to prevent them happening again?¹,² • What is your best guestimate on how many programming visits I can expect in the first year, and will I be able to do any microadjustments on my own?¹,⁴ • If I am not a candidate now, what would you recommend to help be best stabilize or clarifying first?¹,⁴

Sadly, some people are not a candidate to have DBS for what they deal with. We wanted to look at this with sources to show what the science says, in addition to what you need to know when you visit your medical team. As with other FAQs, you will find the Source material for this FAQ in the Source section at the end. Why are some people not DBS candidates? Deep brain stimulation (DBS) can be life changing for so many people, and it has been for over 400,000 people internationally, but it only helps certain symptoms in specific diagnoses, and it does require surgery plus with ongoing programming visits.²,³ So when a medical team says that you're not “not a candidate,” it usually means one of two things: • The expected benefit is too low because the symptoms you have now are unlikely to respond.³,⁴ • The risk is too high right now, because of thinking, mood, medical, or brain imaging concerns, which is determined in the pre-testing phase of DBS determination, and your medical team will go over those results with you. If they don't . . . ask them WHY?!¹,² But, remember that sometimes “not a candidate today,” is just for now, and doesn't always mean “never,” especially if the main barrier is something that can be treated or stabilized first.²,³ What diagnosis related reasons may make someone a poor candidate? A common reason is often unclear or there may be an incorrect diagnosis for the symptom pattern which you are currently being treated for. For example, DBS outcomes are typically best established for certain movement disorders and specific FDA labeled indications, and response may be limited in atypical parkinsonism, also called Parkinson’s plus syndromes.³,⁵,⁶ Another reason could be that when the most disabling symptoms are not the ones DBS usually is considered to improve. In Parkinson’s disease, for instance, certain symptoms that don't improve with levodopa may not improve with DBS either, so levodopa responsiveness is a key part of selection, specifically for Parkinson's.³,⁷,⁸ Why can dementia or significant cognitive problems rule someone out? Many DBS programs consider dementia, also called "Major Neurocognitive Disorder," is a strong reason not to have DBS surgery, because it raises concerns about safety, recovery, and the long-term adjustment that some experience to the DBS electrodes in the brain.¹,³,⁷,⁹ In terms of practibility, DBS requires repeated follow ups, learning how the system works, tracking changes, and communicating clearly about side effects, and significant cognitive impairment can make that what is needed much harder.²,³ If you are told cognition is a concern, you can ask your team: • Do you suspect mild cognitive impairment or dementia, and what testing supports that?⁹ • Is there anything reversible that should be checked first, like sleep problems, medication side effects, depression, or vitamin issues?²,³ What mental health concerns can make DBS unsafe, or a reason to pause? Uncontrolled or severe depression, active psychosis, or other unstable psychiatric illnesses can be a reason to delay DBS or decide against it have the surgery for it. It typically depends on the severity and the diagnosis being treated.³,⁷,⁸ Many resources will commonly list severe depression and other serious mood or mental health problems as reasons someone may not be an ideal DBS candidate, but having DBS installed for both movement disorders AND treatment-resistent depression have been done successfull.⁴,¹⁰ Also, best practice reviews and selection discussions emphasize that dementia and significant psychiatric disorders are commonly treated as a reason against having DBS, especially if symptoms are active and not managed well.³,⁷,⁸ If mental health is part of your story, that doesn't automatically close the door for you. It may just mean that your medical team wants a steadier foundation first, so DBS does not land on top of a storm. When you meet with your team, and their first response is not, turn around and ask them how can we make the no become a yes - what do I need to do? Consider these questions: • What mental health support do you need to see, and recommend before making a final DBS decision to not have surgery?²,³ • How will you, as my medical team monitor my mood and thinking before and after surgery, and how can I help?²,³ Can medical problems make someone “not healthy enough for surgery”? Sadly, yes because DBS involves brain surgery, though considered "minimally invasive," along with implanted hardware, so teams have to assess overall surgical risk. Significant uncontrolled medical problems will raise the risk of complications you may experience, and may lead to delaying or declining surgery until conditions are optimized.²,³ And that's a fair consideration for the medical team, not because of the potential liability concerns for them, but because of your overall health. Your overall health pre-surgery helps reduce the healing process post-surgery. But what can this include? This can include, for example, medical instability, inability to safely manage bleeding risk, or active infection concerns, because infections involving DBS hardware can be serious and sometimes require device removal.¹¹ If you take blood thinners, it's not always an automatic “no,” but it does require careful planning and individualized risk assessment with your neurology, neurosurgery, and prescribing teams.¹² That's why you always want to share any medication changes you may have with your primary care doctor with your DBS medical team. This goes as well for cardiologist, endocrinologist and any other specialty medical providers. What brain imaging findings can rule out DBS, or change the plan? Teams often use MRI or other imaging to confirm there are no structural brain problems that would make surgery a higher risk or suggest that there is a different underlying diagnosis.²,³ Some medical centers list brain lesions or other significant brain conditions as a red flag, which become the final reason for not approving DBS surgery.⁶ Also, be aware that your insurance may ask to see your imaging to confirm, because insurance companies are not in the business to lose money, and often look for ways to not cover medical expenses, so . . . the goal is to not give them any reason to not approve your DBS surgery! Now, if imaging is a concern, ask your medical team the following questions: • If you say that my MRI shows concerns, what are those concerns, and how does it change my risk or expected benefit?²,³ • Also, are there other treatment paths that fit my brain findings better?²,³ What practical or support related issues can make DBS unrealistic right now? DBS is not only a procedure, it is a long term therapy that requires programming visits and ongoing follow up.²,³ Many patient education resources emphasize the importance of having enough support, whether from a care partner or family support, to get through all of the surgery recovery, help attend visits, and help you as a patient manage the day-to-day realities of brain surgery, even if considered minimally invasive, for an implanted DBS system.⁴,¹⁰ Remember that this whole DBS process is not about “doing things perfectly,” but it's about having a workable plan. If support is thin, ask your medical team and medical center for care coordination, social work help, available telehealth programming, or if there is a closer clinic that is manageable for your care?²,³ Are there device related “absolute contraindications” people should know before surgery? Yes, and they come directly from the FDA! The FDA will provide safety restrictions for DBS systems. Examples include, and they vary for each manufacturer (Boston Scientific, Medtronic, and Abbot): • Diathermy exposure, (which is the use of high-frequency EMG currents, like radio waves or microwaves, or ultrasound to generate deep heat in body tissues for therapeutic purposes, such as pain relief, muscle relaxation, or destroying abnormal cells,). This is listed as a reason to not have a DBS system installed, due to risk of severe injury.¹³,¹⁴ • Certain MRI setups are will not work with certain DBS systems, especially for some implanted components, and MRI safety depends on the exact device model and MRI conditions used.¹³ • Also, people who can't operate, or do not have the necessary assistance to operate, the patient controller or charging system may be a reason you can't have DBS surgery, and is dependent on the system your medical team installs surgically.¹³,¹⁴ • Lastly, transcranial magnetic stimulation (TMS) is listed as reason to not install in certain FDA labeling, with some labeling listing electroshock therapy as a reason to not have surgery, so planned use should be discussed before implant.¹³,¹⁴ If any of these possibly apply to your specific situation, bring it up early to your team! They can verify the exact labeling for the device being considered and what it means for your plan of care.¹³,¹⁴ If I was told “not a candidate,” what can I do next? You have the right to know, and it's recommended for you to ask for a clear, written reason in plain language. Next, ask whether it's a “not now” or “not likely” situation.²,³ Consider asking your medical team the following: • What is the single biggest barrier to candidacy in my case?²,³ • Are there steps I can take, and that we can take, to better clarify my diagnosis, stabilize any mood concerns, improve my quality of sleep, or adjust medications, and then re-evaluate?²,³ Also, remember that you pay for your testing. You can request copies of your test results before you leave your "No" session with your medical team, and tak those to another medical team for a second opinion to another DBS medical team and center. That is your right!²,³

What is a DBS referral, and who usually starts it? A DBS referral is the step where you connect with a clinician from a medical team to see if deep brain stimulation could fit your goals and symptoms.²,³ Often it starts with the specific type of medical professional that specializes in the focus that you are interested in getting a DBS system installed for. Ultimately your referral would go from your specialist to a neurosurgery medical provider group. When is it a good time to ask about a referral? Many people ask about DBS when symptoms remain disabling even after a strong medication plan that just doesn't seem to be working to your desire or requirments, or when medication side effects and “wearing off” cycles make daily life harder to predict.²,⁵ If you are unsure, a practical way to frame the question the the neurosurgery team would be the following: “Would a DBS evaluation help clarify my options, even if I am not ready for surgery?” all That is a reasonable use of a first evaluation.²,⁴ Do I need to be “100% sure” I want DBS before I get referred? No. A referral and first evaluation are often about learning, clarifying diagnosis, and mapping options,²,⁴ and many programs treat evaluation as decision support, not a commitment to surgery.²,⁷ What kind of center should I look for? Many resources recommend being evaluated at a center with specific DBS experience and a multidisciplinary team, meaning several specialties working together.⁴,⁸ This team approach is often emphasized because DBS includes diagnosis confirmation, surgical planning, programming, and long term follow up.¹,²,⁸ It's important to share that DBS pathways to treatment and medical team roles can vary across countries and health systems, even when the same conditions are treated.⁸ What should I gather before the first DBS evaluation? Having a clear all of your information collected and organized so that the first visit goes as smooth as possible. Having this information does a couple of other important things by giving you a better snapshot of all the treatment plans you are currently under, and it also helps reduce your anxiety during this visit. Now, many DBS medical teams will review some of the following information: • Your current medication list, including doses and timing.²,⁷ • Prior medications you tried, the side effects, and why (if any) changes were made.² • Any brain imaging you may have already had (reports, and the actual images if possible).²,⁷ • Recent clinic notes from neurology, psychiatry, therapy, or rehabilitation if relevant.²,⁷ Something else you can do is to start, if you haven't already, a symptom diary. This can include “on/off” times, any falls or episodes where stress and events happened that made your life difficult and specific to the condition you need new treatment (DBS). and can include which tasks are hardest, and for example with epilepsy it can include a seizure diary.²,⁷ What happens at the first evaluation appointment? Your first DBS evaluation usually includes, but isn't limited to, a detailed history and exam, then a discussion of goals and expectations.²,⁷ Many centers use a structured screening process that can include neurological evaluation, neurosurgical consultation, and a plan for additional testing.¹,² You need to be completely honest with answering any questions your medical team ask because many of their questions let them know other considerations and unrealized (by you) parts of what you are dealing with that may effect other parts of your care. Don't be afraid to speak up. We will address more of this in the Advocacy part of the website! Now, some medical teams and hospital systems may introduce an offical "DBS coordinator", who is a person who helps organize testing, scheduling, and device education across visits.²,⁷ This person's job to ease tension and expectations for you as a patient. They work for you, work around your schedule and help make the DBS process so much easier for you! Why do DBS teams emphasize goals so early? DBS will work best when you and your medical team agree on the main target symptoms and what “success” could possibly look like in daily life.²,⁹ Your medical team is not new to this process, and pull from experience across a wide spectrum of patient outcomes, so realize any "negative" effects may not be specific to what you may experience. Remember, what "good" and "bad" possibilities are not guaranteed for your outcome! Everyone is biologically unique and your treatment plan must be unique to your current needs, and future goals! This is why goal setting with your medical team is important. It also helps your medical team help choose the most appropriate brain target and design a realistic programming plan.²,⁹ What tests are commonly ordered after the first visit? Testing is going to vary with each treatable condition, the medical team that includes traditional and specialty members and the medical center, All of this can include, but not limited to: • A brain MRI, that is used for surgical planning and is used to look for indications that could change your risk or diagnosis.¹,² • A physical exam, usually by a primary care provider that does an indepth look into your respiration and cardiological systems. If there are questions, they will typically refer you to a specialist to best diagnose concerns that may, or may not, effect your ability to have DBS surgery. This can also include an extensive blood panel • Neuropsychological testing, which evaluates memory, attention, processing speed, and related skills, and is commonly recommended before DBS to support safety and planning.⁴,⁷,¹⁰ This test is usually 1 to 2 hours long, and asks many of the same questions on various places on a spectrum of difficlution. A question is often asked in a non-stress/easy form and again later in the test in a stressful/harder form. There are questions no one is expected to answer, and questions everyone is expected to be able to handle. • Psychiatric or psychological evaluation, when relevant, is used to help understand your current mood, anxiety, coping mechanisms, and stability before the DBS decision moves forward.¹,² What is “on/off testing,” and does it mean I am being judged? If you are dealing with a condition, like Parkinsons, "on/off testing" will be done. This is a structured exam that compares your symptoms in two states, usually off medication and then after medication, to see your symptoms respond.¹,⁵ Again, specific to Parkinson's, many centers use it because the levodopa response is often linked to the likelihood that DBS will improve specific motor symptoms.⁵,⁶ It's not a pass or fail test. It is more like turning the lights on and off in a room to see what changes, then using that information to plan the safest next step.¹,⁵ How does the team decide if I move forward as a DBS candidate? Many DBS teams will discuss cases in a multidisciplinary conference, (where everyone gets together to talk about your specific case), all after testing is complete. They will weigh the likely benefit, risk, diagnosis confidence, and your goals to make the appropriate decision.¹,²,⁸ If they say “yes”, this can often means: • Your diagnosis and target symptoms are a good match for DBS.²,⁹ • Your evaluation suggests you can safely undergo surgery and manage the long term therapy.¹,² • The expected benefit fits what matters most to you.²,⁹ If it's “not right now” this often means the team only wants to stabilize something you may be dealing with first, like mood, sleep, medical issues, or diagnostic uncertainty, and then they will re-evaluate.²,⁷ Will insurance be discussed at the first evaluation? Often, yes. Many DBS programs help patients understand what documentation is needed for insurance authorization, and what parts of evaluation and surgery usually require approval.²,⁷ Because coverage rules differ, your medical team's insurance coordinator would become part of the process.² That's what they do . . . for you! Now, coverage and referral requirements can differ widely outside the United States, including wait times, approval pathways, and device availability.⁸ Some countries like Canada have a socialized medicine system where the process can take up to a year before approval and/or the DBS surgery can be done. This is not to scare you, but to help you realize that your care is important enough to address as soon as possible. You are the one with the sense of urgency, and the only time these non-United States care centers and governmental pay systems see it as urgent will be based on your current state of illness and symptoms. Be vocal about your needs! How soon does programming happen if someone proceeds to surgery? Programming is part of the DBS therapy and is typically started after surgery, sometimes 2 to 3 weeks later, depending on the center’s protocol and recovery plan.³,¹¹ Programming can often require multiple visits because settings are adjusted gradually to balance symptom relief and side effects.¹² We have addressed this previously, but it is an important part of this topic! Lastly, what if I live far away, have limited transportation, or can't come often for post-surgical visits or programming? This is super important to discuss early on in the process! DBS is not only surgery, it is ongoing care.² Some medical centers may share care with your medical team. They may have structured follow-up pathways, or even use telehealth for parts of education and coordination when appropriate.²,⁷ If travel is a barrier, it does not mean “no,” but it does mean best practice planning has to be part of the conversation!²

Outside of the importance of the choice to have DBS surgery, most don't realize that they are the one that ultimately hold the keys to their health care decisions. Yes, you have a medical team. Yes, they provide the testing and consultation to their best view and recommendation for the therapeutic value of DBS for your specific condition, however . . . You have rights! The right to say yes. The right to say, "not right now." And the right to say . . . "I think I want a second opinion!" Most medical teams will not be angry at you letting them know you would like a second opinion. Honestly, most of them on your team will get it. Many neurosurgeons exist in a confident state that they can "fix you," which is a trait you want in a neurosurgeon. Don't let them sell you on their opinion and plan of care being the only option and plan of care for you! You experience what you experience . . . daily. Your medical team sees you intermittently and via phone calls or telehealth. This is also why you should keep a medical journey, as mentioned earlier, for your experiences and symptoms. This is also why we recommend getting all of your medical test results which can include imaging (MRI, CAT Scans) and the affiliated reports, any blood work, and any other results that would be relative to your specific condition, disorder, or disease state that you are seeking DBS therapy. What is a “second opinion” in DBS care? A second opinion simply means that another qualified medical team, or DBS team, will review your diagnosis, symptoms, medical records, and treatment plan, then share their view on your best practice options and next steps.¹,² It can confirm the original plan, refine it, or suggest a different path.¹,³ If you like your original medical team, this is a great way to gain a greater trust by getting another view that would support their proposed plan for your care! In DBS, a second opinion often focuses on: • Diagnosis clarity, because DBS results depend heavily on treating the right condition.⁴,⁵ • Symptom targeting, meaning which symptoms are most likely to respond to DBS.⁴,⁵ • Safety screening, including thinking (cognition), mood, medical risks, and imaging.⁴,⁶ Is it “rude” or disloyal to ask for a second opinion? Not at all! This is YOUR care! Many medical ethics and patient education resources describe second opinions as a normal part of good care, especially when decisions are complex or high impact.¹,² A supportive medical team will usually see it as a way to strengthen the patient and medical team trust and understanding. More often than not they won't see it as a personal challenge.² When should I strongly consider a second opinion for DBS? This is probably the biggest question you could ask, because it can help alleviate stress and anxiety about a serious surgery with serious potential implications! A second opinion may be especially helpful when you experience the following "Red Flags": • You feel unsure about the diagnosis, or you were told different diagnoses by different clinicians.⁴,⁵ • DBS is being recommended quickly, but you do not yet feel informed about risks, benefits, and alternatives.³,⁷ • You were told you are not a DBS candidate, but the reasons felt unclear, rushed, or not well explained.⁴,⁶ • You have complex symptoms, significant mood concerns, or changes in memory or thinking that you think wasn't as thoroughly or carefully evaluated.⁴,⁶ • Your goals, and your voice, are not being heard, or if you feel this medical team is pressuring you toward "the only option."³,⁷ • And lastly, if you live far away and want to confirm that travel, follow-up, and programming needs are realistic for your life.⁴,⁶ Remember . . . a second opinion, is your choice to be respected, your right as a patient or care partners, and also as a tool to remove "red flags" you may feel, and help build trust with your current medical team. When might a second opinion be most useful, before or after the first DBS evaluation? Earlier is easier. Earlier is better! Getting a second opinion before the decision to have DBS surgery helps you feel grounded and informed. It gives you a clearer understanding to your plan, the risks and benefits, and ulitmately the alternatives that help you make the clearest choice that is best for YOU! Again, you are the best advocate you will ever have. Your voice and your right ultimately determing the best practice, along with the one, or two, consultations from a medical team.³,⁷ With that said, a second opinion can still help after an evaluation, especially if you want another team to review your testing results (imaging, neuropsychological testing, medication response testing) and how those results shaped the recommendation.⁴,⁶ What kind of specialist should I look for? For DBS decisions, many medical team experts will review and evaluate your results, and this is typically done by an experienced, multidisciplinary team, usually including your medical specialist who has forwarded you to a DBS medical team, a functional neurosurgeon and his team, and often neuropsychology and psychiatry or psychology.⁴,⁶ Let's look at a few examples: • Parkinson’s disease or tremor: a movement disorder specialist is often the key neurologist to include.⁴,⁸ • Epilepsy: an epilepsy medical team is often important because seizure classification and treatment history matter.⁶ • OCD or other psychiatric indications: a team experienced in psychiatric DBS evaluation is important because candidacy and outcome measures differ.⁶ The exact team structure and access pathways vary by country and health system.⁶,⁹ What should I bring or send for a high-quality second opinion? We've touched on this before, buts econd opinions are stronger when the reviewing medical team has a full picture of where you were, are and potentiall will be based on the disorder, condition, or disease you are seeking DBS therapy for. This is why we recommend you gathering all of your tests, results, and records in advance.¹⁰,¹¹ Helpful items include: • Neurology notes, surgical notes (if already implanted), and clinic letters.⁴,¹⁰ • A complete medication list with doses and timing.⁴,⁶ • Prior medication trials and side effects, especially for Parkinson’s disease, tremor, dystonia, epilepsy, or OCD.⁴,⁶ • Imaging reports (MRI and CAT Scan) and the actual images on disk or electronic transfer, not just the written report.¹⁰,¹¹ • Neuropsychological testing reports, if done.⁴,⁶ • Your symptom diary.⁴,⁶ • A short goal list, written in plain language, like “steady walking in the grocery store” or “less wearing off by afternoon.”⁴,⁶ How do I ask my current clinician for a second opinion without creating conflict? Keep it simple and steady! Use the following to statements, in your own verbage, as two examples: • “This is such a big decision for me, and I think it's best for me to seek a second opinion so I can make the best choice for me.”¹,² • “Since I don't have my records from our visit, can you print out copies of the notes from our visit?”¹,¹⁰ The American Medical Association has an ethics guide that describes consultation and referral, including second opinions, as part of promoting your best interests, and it supports respectful collaboration with your medical team.¹ Most countries outside of the United States have similar guides! How do I choose where to get the second opinion? Consider choosing a medical team and a medical center that: • Performs DBS regularly and provides long-term programming and follow-up, not only surgery.⁴,⁶ • Uses a multidisciplinary review process for candidacy decisions.⁴,⁶ • Has experience with your specific diagnosis and main symptoms.⁴,⁶ Now, if you already have a DBS device and outcomes are not what you hoped, some major centers explicitly offer DBS second opinions for troubleshooting, programming review, or revision evaluation when appropriate.¹² Your voice and patient care outcomes isn't just for before your DBS surgery, it's also during and post-surgery! Can a second opinion be “virtual,” and is it still worth it? Sometimes it can be, but face-to-face second opinons have a greater weight than in a virtual visit. If at all possible, face-to-face helps in getting those providing the second opinion the opportunity to see and hear at a better level than perceptions through virtual visits. Some medical health systems offer virtual second opinion pathways for record review and consultation, especially when travel is difficult.¹³ This is the best option if travel is the concern. A virtual second opinion can be useful for diagnosis review, goal alignment, and plan comparison, as long as the reviewing team has strong records and understands what requires an in-person exam or testing.¹³ When you are talking with the team that you are considering for a second opinion, ask directly the following: • “What can you, and can't you, decide from viewing my records alone?”¹³ • “What would require an in-person exam or testing at your center?”⁴,⁶ Also remember that if it is a virtual second opinion, you still need to get your medical tests and records for them to review, so plan on having your only copies delivered and returned, or have all of your contact ready to request to be sent to this new medical team for evaluation. Will insurance cover a second opinion for DBS? Coverage is going to depend on your current insurance plan and the medical center you hope to meet with. In the US, Medicare states you have the right to a second opinion for surgery or a major therapeutic procedure, and if the first two opinions differ, a third opinion may be covered under plan rules.¹⁴ It may differ your location outside of the United States. If cost is a concern, here are some questions you can ask your insurance company or medical providers: • “Is this second opinion in-network?”¹⁴ • “What codes are billed for the consult, and do you require preauthorization?”¹⁴ What should I ask during a DBS second opinion visit? Here are some questions to help keep the conversation clear and practical: • What diagnosis are you treating, and how confident are you?⁴,⁵ • Which symptoms are most likely to improve with DBS, and which are unlikely to change?⁴,⁶ • What testing do you rely on most for candidacy, and why?⁴,⁶ • If you disagree with the first team, what is the main reason, and what evidence supports your view?³,⁴ • What are the realistic risks for someone with my health profile, and how do you reduce them?⁴,⁶ • How many programming visits do you expect in the first year, and what support is available if I live far away?⁴,⁶ • What non-surgical options should be considered or optimized first?³,⁴ Alot of these questions, are very similar to what you ask during your first consult. Use your experience from the first initial consult as a guidance. What if the second opinion disagrees with the first? If the opinions differ, it doesn't automatically mean that someone is “wrong.” It often means there is one or more medical teams are uncertain in your diagnosis and treatment options. There may be different interpretations of your testing, or different comfort levels with risk and expected benefit.³,⁴ This is where you have to rely on your own best education on your care. Read as much as you can, and look at the sources in the Sources FAQ to reasearch and educate yourself! It may be helpful to ask both teams to explain, in plain language: • What facts they agree on. • What facts they interpret differently. • What outcomes they think are realistic, and why.³,⁴

So, you have made the initial visit. You may have had your second opinion. The amount of questions, answers and information overall can be a bit frustrating. It can also be a super easy decision. It's all going to be based on your choice, and one of the most important factors can be wrapped in anxiety and uncertainty. Completely understandable! We've all been there, but ultimately it will be your decision, with one or more consultations with DBS medical teams. From our personal experience as a foundation, there has never been a second thought that DBS therapy didn't change our lives! Every choice you make about your DBS journey has to include the influence of one topic: Quality of Life! We hope this section helps you see this! What is the goal of a DBS evaluation? A DBS evaluation is the structured way to answer two big questions: "Is DBS likely to help your most important symptoms," and "is it likely to be safe for you."¹,² Many DBS programs use the multidisciplinary team approach, meaning several specialists review the same story from different angles, then make a recommendation together.¹,³ What kinds of “information” come out of a DBS evaluation? Most evaluations produce a few types of information that fit together like pieces on your unique map, most of which we have already addressed but bears repeating: • What is your medical team's diagnosis confidence, meaning how sure they are about what condition is treatable.²,⁴ • What is your symptomtomic responsiveness. This means which of your symptoms change with medication, and which do not.⁴,⁵ • Brain imaging findings, often MRI, used for planning and safety screening.¹,² • Thinking and mood screening, often neuropsychological testing plus psychiatric evaluation when needed.¹,⁶,⁷ • Lastly, a practical plan of care, meaning that the follow-up schedule, the programming needs, and the expectations of long-term device management.²,⁸ What does “multidisciplinary team” really mean, and why should I care? It means that decisions are not made by one person alone. DBS care often involves your condition specialist, neurosurgery, and commonly neuropsychology and mental health specialists, because DBS is both a surgery and a long-term therapy that requires adjustment over time.¹,²,³ This "team" approach is commonly described as "best practice" because it looks at optimizing safety, sets realistic expectations, and strengthens the match between symptoms and target.¹,³ What if my symptoms do not improve much with medication during testing? If a symptom doesn't respond to medication typically used to treat your condition, DBS may be less likely to improve that symptom in the typical disease treatment plan that you have tried, and the team may explore whether the diagnosis is correct, whether medication was properly optimized, or whether a different treatment strategy fits better.⁴,⁵ This doesn't mean that nothing can improve, but it changes expectations and sometimes changes the plan.⁴,⁵ How should I interpret neuropsychological testing results? As we mentioned in another FAQ, neuropsychological testing looks at thinking skills like memory, attention, processing speed, and problem solving, and it often includes mood screening.⁶,⁷ Many DBS programs consider it an important part of evaluation because cognitive health can affect surgical safety, recovery, and long-term adaptation to device management and follow-up.¹,⁶,⁷ Typically, you will visit first with the neuropsychologist to review your test results before it is sent to the rest of you medical determination team. If your neuropsych report seems confusing, ask for a plain-language summary of: • What are the strengths that support DBS success?⁶,⁷ • What are your vulnerabilities, like slowed thinking or memory concerns, and what they might mean for potential risk?⁶,⁷ • Can you explain whether the results that may suggest mild cognitive impairment versus dementia, since that distinction matters greatly in the DBS planning determination⁶,⁷ How should I interpret psychiatric evaluation findings? A psychiatric or psychological evaluation can help clarify mood symptoms, anxiety, coping resources, and stability.¹,² It's often used to reduce risk and to make sure the emotional load of surgery and follow-up is not landing on an already overwhelmed system.¹,² If mood symptoms are active, many teams focus first on stabilization, then revisit DBS once the ground feels steadier.²,⁴ Often many who do have DBS surgery often experience anxiety post surgery, where they didn't experience pre-surgery. It's important to address these concerns early in the process, and make plans to address post-surgery if it does seem to be affecting you negatively. What does MRI Imageing contribute to the decision about approval of your DBS Surgery? MRI is commonly used to: • Help plan safe lead placement and surgical trajectories, through what is called "Brain Mapping," which is more specific and detailed to your specific brain infrastructure. You may have the same condition being treated with DBS as another person, but the perfect target for your electrode placement may be 1 to 2 mm different from everyone else.¹,² • The MRI can also check for indications that might increase surgical risk or suggest another diagnosis.¹,² • It can also provide best practice device safety planning, since MRI rules depend on the implanted system and scan conditions.² If MRI is not possible for you, some medical centers, and medical teams, use other imaging approaches and tailor planning based on safety needs.² It typically depends How do I weigh “benefits” in a realistic way? Benefits are most useful when they are tied to your specific medical condition and symptoms, along with your daily life goals and quality of life, not just based on some "medical label."²,¹⁰ During the evaluation process, medical determination teams often work to connect the dots of your symptom patterns to what DBS is known to help, then translate that into what you might notice day to day.²,¹⁰ Again . . . it is about your decision, desired outcomes, and quality of life hopes! A better question to ask yourself is this: “Which specific moments of my day do we think might get easier, and why?”² How do I weigh “risks” without getting overwhelmed? DBS isn't without potential, but rare, risks because it is brain surgery with implanted hardware, but this is why all of the specific medical screening is designed to reduce those risks.¹,¹¹ Ask your team to describe risks in three buckets: • Surgical risks: Meaning what are the risks during or soon after the procedure.²,¹¹ • Hardware risks: Meaning what are risks for infections or device issues recently after surgery all the way to periods of time in the future.²,¹¹ • Therapy risks: Meaning what are the ripple effects from the stimulation settings, which may can be potentiall adjusted through programming.²,⁸ It may be good to ask for your medical team and their medical center to provide their own complication rates and how they compare with published experiences elsewhere, because risk can vary by population and program.²,¹¹ What does “risk-benefit” mean in plain language? This "risk-benefit" term means that your medical team is asking you and considering themselves if the changes you might gain be worth the unexpected ripple effects you may carry, given your health, diagnosis, goals, and support.²,¹⁰ Sometimes the decision is clear. Sometimes it's a close call, and in those close-call situations, your values matter the most, especially around quality of life, independence, the future need to travel for continued care and programming maintenance, ripple effects you can (and may not) tolerate, and what outcomes feel meaningful to you.²,¹⁰ What are common reasons a team may say “not now” instead of “no”? A “not now” recommendation often means something can be improved first, such as: • Diagnosis clarity for when symptoms don't fit the hoped for result.⁴,⁵ • Medication optimization, when trials were incomplete or dosing timing needs refining.⁴,⁵ • Mood or sleep stabilization, when mental health or fatigue is actively worsening daily function.²,⁴ • Cognitive clarification, when testing suggests higher risk and more evaluation is needed.⁶,⁷ This is not a closed door to DBS surgery but often a simple pause to reduce any potential harm and focused on increasing the chance of a good outcome.²,⁴ What questions should I ask at the “results review” visit? These questions keep the conversation concrete: • What diagnosis are you treating, and how confident are you?²,⁴ • Which symptoms do you expect DBS to help most, and which are unlikely to change?²,⁴ • What did my on/off testing show, and how does it shape expectations?⁴,⁵,⁹ • What did my neuropsych testing show, and what risks does it raise, if any?⁶,⁷ • What are the most likely side effects for my target and my symptoms, and how are they managed through programming?²,⁸ • How many programming visits should I expect in the first year, and what does long-term follow-up look like?²,⁸ • What alternatives should we consider, including non-surgical options or other procedures?² How can I organize my information so the decision feels clearer? This probably the most important part you can play in your own health care decicions! Many find it helps to use a one-page “decision sheet” you can bring to appointments. This is educational, not medical advice, and will be available in the near future for you to download and print to help you organize your thoughts, desires and goals. • What are ny top 3 symptoms to improve: • What are my top 3 daily-life goals: • What do I look for in how DBS can help my symptoms: • What am I not expecing DBS to help: • What are key risks that apply to me and what am I willing to live with, and without: • How will I handle follow-up and potential travel to issues: You may still feel that many of your questions are unanswered. These kinds of questions will help you understand when your medical team asks you to sign the informed consent for DBS Surgery. Typically this means that you understand the plan, risks, benefits, and alternatives well enough to choose with clarity.¹² Remember that after you evaluate all of your test results, the consulation from your medical team, either after the first or second opinion, it is ultimately you that make the best decision for your health care decisions. We at the NeuroSpark Foundation understand that DBS surgery and neurostimulation therpay is NOT for everyone, but you are the only one with the right to make that decision for yourself and your quality of life!

Who IS a Candidate Sources: 1. Abboud H, Floden D, Thompson NR, et al. Comprehensive, multidisciplinary deep brain stimulation screening and programming. Front Hum Neurosci. 2014;8:1-10. Accessed December 14, 2025. h(https://pmc.ncbi.nlm.nih.gov/articles/PMC6183455/?utm_source=chatgpt.com)ttps://pmc.ncbi.nlm.nih.gov/articles/PMC6183455/ (https://pmc.ncbi.nlm.nih.gov/articles/PMC6183455/?utm_source=chatgpt.com) 2. Dallapiazza RF, Lee DJ, De Vloo P, et al. Considerations for patient and target selection in deep brain stimulation. In: StatPearls. Updated 2018. Accessed December 14, 2025. h(https://www.ncbi.nlm.nih.gov/books/NBK536714/?utm_source=chatgpt.com)ttps://www.ncbi.nlm.nih.gov/books/NBK536714/ (https://www.ncbi.nlm.nih.gov/books/NBK536714/?utm_source=chatgpt.com) 3. National Institute of Neurological Disorders and Stroke (NINDS). Deep brain stimulation (DBS) for the treatment of Parkinson’s disease and other movement disorders. Updated December 3, 2024. Accessed December 14, 2025. h(https://www.ninds.nih.gov/about-ninds/what-we-do/impact/ninds-contributions-approved-therapies/deep-brain-stimulation-dbs-treatment-parkinsons-disease-and-other-movement-disorders?utm_source=chatgpt.com)ttps://www.ninds.nih.gov/about-ninds/what-we-do/impact/ninds-contributions-approved-therapies/deep-brain-stimulation-dbs-treatment-parkinsons-disease-and-other-movement-disorders (https://www.ninds.nih.gov/about-ninds/what-we-do/impact/ninds-contributions-approved-therapies/deep-brain-stimulation-dbs-treatment-parkinsons-disease-and-other-movement-disorders?utm_source=chatgpt.com) 4. Mahajan A, Sonti S, Fox SH, Lozano AM. Global variability in deep brain stimulation practices for Parkinson’s disease. Front Hum Neurosci. 2021;15:667035. Accessed December 14, 2025. h(https://www.frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.667035/full?utm_source=chatgpt.com)ttps://www.frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.667035/full (https://www.frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.667035/full?utm_source=chatgpt.com) 5. US Food and Drug Administration. Premarket Approval (PMA) P960009/S478: Indications for use, Medtronic DBS therapy for Parkinson’s disease (includes levodopa responsive PD of at least 4 years’ duration statement in IFU). Accessed December 14, 2025. h(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S478&utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S478 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S478&utm_source=chatgpt.com) 6. US Food and Drug Administration. Premarket Approval (PMA) P960009: Decision date July 31, 1997, Medtronic Activa Tremor Control System. Accessed December 14, 2025. h(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009&utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009&utm_source=chatgpt.com) 7. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED) P960009/S007B: Tremor Control System indication and approval history. Published March 31, 2000. Accessed December 14, 2025. h(https://www.accessdata.fda.gov/cdrh_docs/pdf/p960009s007b.pdf?utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/cdrh_docs/pdf/p960009s007b.pdf (https://www.accessdata.fda.gov/cdrh_docs/pdf/p960009s007b.pdf?utm_source=chatgpt.com) 8. US Food and Drug Administration. Premarket Approval (PMA) P960009/S219: Medtronic DBS System for Epilepsy, anterior nucleus of the thalamus indication statement. Accessed December 14, 2025. h(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p960009s219&utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p960009s219 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p960009s219&utm_source=chatgpt.com) 9. US Food and Drug Administration. Humanitarian Device Exemption (HDE) H020007: DBS for dystonia indication statement (primary dystonia, age 7+). Accessed December 14, 2025. h(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375511&utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375511 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375511&utm_source=chatgpt.com) 10. US Food and Drug Administration. Humanitarian Device Exemption (HDE) H050003: Reclaim DBS therapy for OCD, indication statement (decision date February 10, 2009). Accessed December 14, 2025. h(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375533&utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375533 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=375533&utm_source=chatgpt.com) 11. National Institute for Health and Care Excellence (NICE). Deep brain stimulation for Parkinson’s disease (IPG19), guidance and patient selection with multidisciplinary involvement. Published November 26, 2003. Accessed December 14, 2025. h(https://www.nice.org.uk/guidance/ipg19/chapter/1-guidance?utm_source=chatgpt.com)ttps://www.nice.org.uk/guidance/ipg19/chapter/1-guidance (https://www.nice.org.uk/guidance/ipg19/chapter/1-guidance?utm_source=chatgpt.com) 12. Artusi CA, Dwivedi AK, Romagnolo A, et al. Deep brain stimulation selection criteria for Parkinson’s disease: time to go beyond the classic model? J Clin Med. 2020;9(12):3931. Accessed December 14, 2025. h(https://pmc.ncbi.nlm.nih.gov/articles/PMC7761824/?utm_source=chatgpt.com)ttps://pmc.ncbi.nlm.nih.gov/articles/PMC7761824/ (https://pmc.ncbi.nlm.nih.gov/articles/PMC7761824/?utm_source=chatgpt.com) 13. US Food and Drug Administration. Premarket Approval (PMA) P960009/S007: Decision date January 14, 2002, Activa Parkinson’s Control System (DBS for Parkinsonian symptoms). Accessed December 14, 2025. h(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S007&utm_source=chatgpt.com)ttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S007 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S007&utm_source=chatgpt.com) 14. University of Florida Health. Who is a candidate for DBS? Essential tremor candidacy and medication refractory definition discussion. Accessed December 14, 2025. h(https://movementdisorders.ufhealth.org/for-patients/deep-brain-stimulation-information/uf-what-a-patient-needs-to-know-about-dbs/who-is-a-candidate-for-dbs/?utm_source=chatgpt.com)ttps://movementdisorders.ufhealth.org/for-patients/deep-brain-stimulation-information/uf-what-a-patient-needs-to-know-about-dbs/who-is-a-candidate-for-dbs/ (https://movementdisorders.ufhealth.org/for-patients/deep-brain-stimulation-information/uf-what-a-patient-needs-to-know-about-dbs/who-is-a-candidate-for-dbs/?utm_source=chatgpt.com) 15. Zesiewicz TA, Elble R, Louis ED, et al. Evidence-based guideline update: Treatment of essential tremor. Neurology. 2011;77(19):1752-1755. Accessed December 14, 2025. h(https://www.neurology.org/doi/10.1212/WNL.0b013e318236f0fd?utm_source=chatgpt.com)ttps://www.neurology.org/doi/10.1212/WNL.0b013e318236f0fd (https://www.neurology.org/doi/10.1212/WNL.0b013e318236f0fd?utm_source=chatgpt.com) 16. US Food and Drug Administration. Humanitarian Device Exemption (HDE): overview and definition. Published January 13, 2025. Accessed December 14, 2025. h(https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption?utm_source=chatgpt.com)ttps://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption (https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption?utm_source=chatgpt.com) 17. US Food and Drug Administration. Humanitarian Use Device (HUD) designation program overview. Published December 15, 2023. 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Accessed December 14, 2025. h(https://pmc.ncbi.nlm.nih.gov/articles/PMC8386520/?utm_source=chatgpt.com)ttps://pmc.ncbi.nlm.nih.gov/articles/PMC8386520/ (https://pmc.ncbi.nlm.nih.gov/articles/PMC8386520/?utm_source=chatgpt.com) 2. Dallapiazza RF, Lee DJ, De Vloo P, et al. Considerations for patient and target selection in deep brain stimulation. In: StatPearls. Updated 2018. Accessed December 14, 2025. h(https://www.ncbi.nlm.nih.gov/books/NBK536714/?utm_source=chatgpt.com)ttps://www.ncbi.nlm.nih.gov/books/NBK536714/ (https://www.ncbi.nlm.nih.gov/books/NBK536714/?utm_source=chatgpt.com) 3. Hartmann CJ, Wojtecki L, Vesper J, Schnitzler A. An update on best practice of deep brain stimulation in Parkinson’s disease. Ther Adv Neurol Disord. 2019;12:1756286419838096. 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