Focused ultrasound (MRgFUS thalamotomy, capsulotomy, low-intensity)

1. Introduction

Version followed: US FDA approvals of the Exablate Neuro MR-guided focused ultrasound (MRgFUS) system as reported by the manufacturer and the Focused Ultrasound Foundation (2016–2025); NICE guidance on unilateral MRgFUS thalamotomy for treatment-resistant essential tremor (patient information, 20 June 2018); published research on investigational MRgFUS capsulotomy (Sunnybrook, Toronto) and low-intensity transcranial ultrasound stimulation. Regulatory status checked October 2026.

Focused ultrasound is not a psychotherapy. It is a device-based procedure delivered by a specialist neurosurgical/neurology team. Three different uses share the name, and a therapist must keep them apart:

• Ablative MRgFUS for movement disorders (approved). Ultrasound beams are converged through the intact skull onto a small target deep in the brain while the patient lies awake in an MRI scanner; the energy heats and permanently destroys a small volume of tissue. For essential tremor and tremor-dominant Parkinson's disease the target is in the thalamus (the ventral intermediate nucleus, as published studies name it); for advanced Parkinson's disease newer approvals cover pallidotomy and pallidothalamic tractotomy. Change happens because interrupting a circuit that generates tremor or other motor symptoms reduces those symptoms on the opposite side of the body. [source: FUS Foundation 2016; NICE 2018; Insightec 2025; Saporito et al. 2024]
• Ablative MRgFUS capsulotomy for psychiatric disorders (investigational). A lesion in the internal capsule (the region named by the procedure) for highly treatment-refractory obsessive-compulsive disorder (OCD) and major depressive disorder (MDD), in research settings only. As of October 2026 the Focused Ultrasound Foundation states that focused ultrasound "is not approved by any regulatory bodies worldwide as a treatment for OCD". [source: FUS Foundation OCD page; FUS Foundation 2024 long-term results summary]
• Low-intensity focused ultrasound (LIFU / transcranial ultrasound stimulation, TUS) (investigational). Non-ablative stimulation intended to modulate, not destroy, brain activity, studied in small trials for depression, anxiety and OCD. [source: Keihani et al. 2024; Cai et al. 2026 as reported by Consultant Live]

The therapist's job is not to deliver any of this. It is to recognise when a referral or research enquiry is reasonable, support informed consent, assess and monitor psychological state before and after, pass on changes to the treating team, plan for crises, and integrate psychotherapy around the procedure. [synthesis] The overlapping topic of open and stereotactic ablative psychiatric neurosurgery and deep brain stimulation is covered in tab 029 Stereotactic psychosurgery; the history of lobotomy and its harms is covered in Domain XVI.

2. Framework

Regulatory status by indication (checked October 2026)

EU/CE-mark, MHRA, Health Canada and other national statuses and the age range in the US labelling are not drawn on here; check the manufacturer's regulatory page or the treating centre. [uncertain] NHS England funding for essential tremor treatment from April 2021 appears only in page metadata, not in a guidance text. [uncertain]

Course of care (approved movement-disorder indication)

1. Referral and screening (neurology/movement-disorder team). Confirmation that tremor has not improved with medication; MR and CT scans to confirm the treatment is appropriate. Exclusions as the Foundation lists them include inability to have MRI (non-MRI-compatible implants, contrast allergy, body size), pregnancy, advanced kidney disease or dialysis, unstable heart conditions or severe hypertension, signs of alcohol or substance misuse, bleeding or clotting disorders, current anticoagulants or drugs raising bleeding risk, history of stroke or brain tumour, and inability to lie still for a prolonged procedure. [source: FUS Foundation 2016]
2. Consent. NICE says patients should be told what the procedure involves, its benefits, risks and how likely they are, what happens if it fails, and their alternatives including declining; clinicians should listen to concerns, and family can be involved if the patient wishes. [source: NICE 2018]
3. Procedure day (single session, team-delivered). A head frame is fitted; the patient lies in the MRI scanner awake and responsive; energy is delivered in steps while the team checks tremor and side effects until tremor reduces. [source: FUS Foundation 2016; NICE 2018]
4. Recovery and follow-up. Regular checks of benefit and complications (NICE). Second side only after a labelled interval and only for appropriate patients (FDA 2022). Research follow-up of cognition and mood at baseline, 6 months and 1 year has been published. [source: NICE 2018; NeurologyLive 2022; Saporito et al. 2024]

Course of care (investigational psychiatric use)

1. Long history of treatment-refractory illness; referral to a specialist centre running a trial. Participants in the Toronto studies were described as "highly treatment refractory". [source: FUS Foundation 2024 summary]
2. Legal and ethics steps: trial ethics approval and, depending on jurisdiction, mental-health-law safeguards for brain-tissue-destroying surgery (see principle 4). [source: Mental Health Act 1983 s57; Victoria Department of Health]
3. Baseline imaging and rating scales (in the Toronto studies the Yale-Brown Obsessive Compulsive Scale for OCD and the 17-item Hamilton Depression Rating Scale for MDD). [source: FUS Foundation 2024 summary]
4. Procedure by the neurosurgical team.
5. Long follow-up: Toronto outcomes were reassessed at 6 and 12 months and again at 18–24 months; OCD responses grew over time. [source: FUS Foundation 2024 summary] Victoria requires reports to the Chief Psychiatrist within three months and again at 9–12 months after neurosurgery for mental illness. [source: Victoria Department of Health]

Therapist's parallel framework [synthesis]

3. Guiding principles

1. Stay in your lane, actively. You do not assess eligibility, recommend the procedure or comment on targeting; you help the client use the specialist system well. Practical meaning: every medical question goes to the team, with your notes on what the client wants to ask. [synthesis]
2. Approved is not the same as investigational. Tremor treatment is an approved procedure; capsulotomy and low-intensity ultrasound for psychiatric illness are research. Practical meaning: speak of psychiatric uses only as "clinical trials", never as an available treatment. [source: FUS Foundation OCD page]
3. Ablation is permanent. MRgFUS thalamotomy, pallidotomy, tractotomy and capsulotomy destroy brain tissue; NICE notes ongoing concerns about long-term effects. Practical meaning: consent conversations must include "this cannot be undone" and what living with a lesion means if benefit is partial or side effects persist. [source: NICE 2018; FUS Foundation 2016] Low-intensity stimulation is intended to be non-ablative, but long-term safety data are limited. [source: Keihani et al. 2024] [uncertain]
4. Psychiatric neurosurgery carries extra legal safeguards. In England and Wales, s57 of the Mental Health Act 1983 covers any surgical operation for destroying brain tissue or its functioning: the patient must consent, and an appointed doctor plus two other appointed people must certify that the patient "is capable of understanding the nature, purpose and likely effects of the treatment" and has consented; the appointed doctor must also certify that it is appropriate, after consulting a nurse and one other professional involved in care. In Victoria (Australia), the treating psychiatrist must apply to the Mental Health Tribunal with the person's written informed consent; no guardian or substitute decision-maker can consent, and the Tribunal weighs likely benefit, consequences of not operating, alternatives and the person's views on risks. Practical meaning: capacity and voluntariness are central; substitute consent is not available in these frameworks. Whether a particular focused-ultrasound capsulotomy falls under s57 is a question for the treating team and legal advisers. [source: mentalhealthlaw.co.uk s57 text; Victoria Department of Health] [uncertain] US state rules are not drawn on here. [uncertain]
5. Voluntariness under desperation. Clients with decades of refractory OCD or depression may agree to anything. Practical meaning: explore pressure from hopelessness, family or services, and make "no" and "not yet" visible options. [synthesis]
6. Psychological baseline before, close watching after. Published tremor studies monitored cognition, mood and anxiety before and after; the authors advise longitudinal assessment because changes may emerge later. Practical meaning: record a baseline in your own notes and agree with the client what changes you will pass on. [source: Saporito et al. 2024]
7. Never imply a change to medical care. Practical meaning: questions about medicines, anticoagulants, the second side or repeat procedures go to the team. [synthesis]
8. Psychotherapy remains part of care. Practical meaning: for psychiatric trial participants, plan in advance how evidence-based therapy (e.g. exposure and response prevention for OCD) will be resumed after the procedure; for tremor patients, address adjustment and any anxiety or low mood. [synthesis]
9. Information comes from the treating centre and regulators. Practical meaning: check claims seen online, including offers of low-intensity ultrasound outside trials, against the regulator, the trial registry and the treating centre. [synthesis]

4. Intervention inventory

Part A describes, at a descriptive level only, what the treating team does, so you can explain it accurately and recognise its effects. Part B is the therapist's own work. No device settings, targeting details or protocol numbers are given; ask the treating centre for anything procedural.

Part A. Treatment delivered by the treating team

A1. Unilateral MRgFUS thalamotomy for essential tremor (approved)

• Purpose: to reduce disabling tremor on one side of the body in essential tremor that has not improved with medication. FDA approved 11 July 2016; NICE (England) guidance 20 June 2018. [source: FUS Foundation 2016; NICE 2018]
• Who delivers: a specialist neurosurgical/neurology team at a centre with the device, working with MRI. [source: FUS Foundation 2016; NICE 2018] The exact team mix varies by centre. [uncertain]
• How it is delivered (descriptive): MR and CT scans beforehand; on the day a head frame is fitted; the patient lies in the MRI scanner, which is used to locate the target in the thalamus; ultrasound energy is delivered in steps through the intact skull until tremor reduces; the patient is awake and responsive throughout so the team can check tremor and side effects. Only one side of the brain is treated, so only one side of the body benefits. [source: FUS Foundation 2016; NICE 2018]
• Adverse effects in the FDA-approval summary: numbness or tingling of the fingers; headache; imbalance or unsteadiness; loss of control of body movements (ataxia) or gait disturbance; tissue damage outside the treatment area; bleeding in the treated area needing emergency treatment; skin burns with ulceration, skin retraction and scarring; blood clots. NICE: "no major safety concerns" but concerns about long-term effects and complications, and uncertainty about function and quality of life when tremor affects both sides. [source: FUS Foundation 2016; NICE 2018]
• Psychological and cognitive effects as reported: in a prospective study of 50 patients (28 essential tremor, 22 Parkinson's tremor) followed for one year without a control group, global cognition, frontal function and verbal memory did not worsen and improved slightly, and depression and anxiety scores improved; no apathy measure was included and psychiatric adverse events were not reported as a separate outcome. The authors recommend longitudinal assessment because changes may emerge later. [source: Saporito et al. 2024] Psychiatric adverse effects are not listed in the FDA-approval summary. [uncertain]
• Watch for (therapist): distress about being awake in the scanner and the head frame; disappointment if benefit is partial; low mood linked to new numbness or unsteadiness. [synthesis]
• Example language (illustrative): "You'd be awake in the scanner with a frame on your head while the team treats one side of the brain, step by step, checking your tremor as they go. It's a permanent change, so it's worth asking them about every risk." [synthesis]

A2. MRgFUS for Parkinson's disease (approved, several indications)

• Purpose: unilateral thalamotomy for tremor-dominant Parkinson's disease (FDA, 18 December 2018); unilateral pallidotomy for dyskinesia and motor symptoms (FDA, 2021); staged bilateral pallidothalamic tractotomy for advanced Parkinson's disease with severe motor symptoms (rigidity, slowness, dyskinesia) not relieved by medication (FDA, announced 8 July 2025). [source: FUS Foundation PD timeline; Insightec 2025]
• How it is delivered: the same awake, MRI-guided, incisionless approach as A1; the bilateral tractotomy is done in two staged procedures. [source: Insightec 2025]
• Watch for (therapist): Parkinson's disease itself carries depression, anxiety and apathy; separate disease-related changes from possible procedure effects only with the team, not on your own. Wider risk profile of the 2025 indication is not drawn on here. [synthesis] [uncertain]
• Example language (illustrative): "For Parkinson's the team now has several approved versions. Which one, if any, fits you is their decision; I can help you prepare your questions." [synthesis]

A3. Treating the second side in essential tremor (approved, staged)

• Purpose: for appropriate patients who benefited from the first side, the second side can be treated after a minimum interval in the labelling. FDA approval 20 December 2022; in the 51-patient study the second-side safety profile was reported as similar to the first side, with mostly mild adverse events. [source: NeurologyLive 2022]
• Watch for (therapist): a client who feels pressured or impatient to have the second side; support the decision process and route timing questions to the team. [synthesis]
• Example language (illustrative): "Treating the second side is a separate decision with its own wait. There's no rush from my side; your team will talk you through timing." [synthesis]

A4. MRgFUS capsulotomy for OCD and depression (investigational)

• Purpose: studied for highly treatment-refractory OCD and MDD. Not approved by any regulator for OCD as of October 2026. [source: FUS Foundation OCD page]
• Where and how: only in clinical trials (e.g. Sunnybrook, Toronto; trial registrations exist for OCD and for anorexia nervosa with comorbid OCD or MDD, and a Taiwan OCD trial is listed as recruiting by invitation). The device is the same MRgFUS system; the lesion is placed in the internal capsule (published work also names ventral capsule/ventral striatum targets). [source: FUS Foundation OCD page; ClinicalTrials.gov record titles NCT06131502, NCT07113665, NCT03156335 (records did not render; titles only)] [uncertain]
• Reported outcomes and adverse effects: in the Toronto open-label studies (15 OCD, 12 MDD, 2017–2023), OCD symptoms fell by about a third at 12 months, with response rates of 42% at one year and 67% at two years; depression reductions were not statistically significant; the authors reported "no serious adverse effects". [source: FUS Foundation 2024 summary of Lipsman and colleagues, Biological Psychiatry] Detailed psychiatric, personality or cognitive adverse effects of focused-ultrasound capsulotomy are not covered here; check the trial's consent information and tab 029 for the wider capsulotomy literature. [uncertain]
• Consent and capacity: see principle 4. Ablation cannot be undone; benefit may take months to appear. [source: FUS Foundation 2024 summary; NICE 2018 on long-term uncertainty for ablation in general] [synthesis for the application to psychiatric use]
• Example language (illustrative): "For OCD this is only available in research trials. If you were offered a place, we'd want to go through the consent information carefully together." [synthesis]
• Watch for: talk of capsulotomy as an available cure, pressure from desperation, and any offer outside a registered trial. Working: the client describes it as research and knows how to check a trial's registration. [synthesis]

A5. Low-intensity focused ultrasound / transcranial ultrasound stimulation (investigational)

• Purpose: non-ablative neuromodulation of deep or cortical regions, studied for depression, anxiety and OCD. A 2024 review describes "only a handful of studies" in psychiatric populations, with several aspects still to be characterised. [source: Keihani et al. 2024]
• Example trial: a single-blind, sham-controlled trial of 36 adults with depression at Shenzhen Samii Medical Center (target region named as the left dorsolateral prefrontal cortex) reported benefit over sham; adverse events in the active arm were two transient headaches and one case of increased mental excitability, with no serious adverse events. [source: Consultant Live 2026 report of Cai et al., J Affect Disord 2026]
• Regulatory status: research only in the sources; no psychiatric approval is described. [uncertain]
• Watch for (therapist): the client being offered stimulation outside a registered trial; agitation, sleep loss or activation after sessions (increased excitability has been reported) passed on to the research team. [source for excitability: Consultant Live 2026] [synthesis for the rest]
• Example language (illustrative): "This is a gentler, research-only form of ultrasound that aims to change brain activity without making a lesion. It's still being tested, so the safest route is through a registered trial." [synthesis]

Part B. The psychotherapist's interventions

All of Part B is [synthesis] built on the sources above unless a source is tagged.

B1. Recognising when to suggest a specialist review or research enquiry

• Purpose: to make sure clients with disabling tremor, or with severe long-standing refractory OCD or depression, know that specialist assessment exists, without promising access or benefit.
• Steps: (1) Note when tremor is causing functional loss, shame, isolation or low mood, or when OCD/depression has not responded to adequate trials of evidence-based psychotherapy and medication. (2) Ask whether the client has discussed specialist options with their neurologist, GP or psychiatrist. (3) For tremor, suggest raising focused ultrasound alongside other options with the neurologist, since the team decides eligibility (exclusions include bleeding risk, some heart and kidney conditions, substance misuse and MRI incompatibility). [source: FUS Foundation 2016] (4) For OCD or depression, frame it as a possible research route via the treating psychiatrist and trial registries, and first check that intensive or specialist psychological treatment has really been tried. (5) With consent, write a brief letter summarising psychological treatment history and current functioning.
• Example language (illustrative): "Your neurologist is the right person to say whether you'd be suitable. Would it help to write down your questions for that appointment?" / "For OCD this is still only available in research studies. Before going there, let's check together what's been tried and how fully."
• Watch for: the client hearing "referral" as "you've given up on me"; online claims that capsulotomy or low-intensity ultrasound is an available cure. Working: the client goes to the appointment with clear questions.

B2. Psychoeducation

• Purpose: an accurate, plain picture of what the procedure is and is not.
• Steps: (1) Ask what they already know and where from. (2) Separate the three uses: approved tremor ablation; investigational capsulotomy; investigational low-intensity stimulation. [source: FUS Foundation OCD page] (3) Explain in plain terms: awake in an MRI scanner with a head frame, no incision, one side treated per procedure, a small permanent lesion. [source: FUS Foundation 2016; NICE 2018] (4) Name the listed side effects without dramatising them. [source: FUS Foundation 2016] (5) Point to the treating centre and NICE patient information for detail; never fill gaps with guesses.
• Example language (illustrative): "It's called non-invasive because there's no cut, but it does make a small permanent change in the brain. That's worth holding in mind alongside the benefits."
• Watch for: "non-invasive" being heard as "reversible" or "risk-free". Working: the client can explain it back accurately.

B3. Supporting informed consent and shared decision-making

• Purpose: help the client reach a free, informed decision and bring good questions to the team. The consent itself is taken by the treating team (and, for psychiatric neurosurgery, under legal safeguards). [source: NICE 2018; s57 text; Victoria Department of Health]
• Steps: (1) Use NICE's list as a structure: what it involves; benefits; risks and their likelihood; what happens if it fails or something goes wrong; alternatives including doing nothing. [source: NICE 2018] (2) Add the permanence question explicitly: what would partial benefit, or a lasting side effect such as unsteadiness or numbness, mean for this person's life? (3) Values clarification: what matters most (e.g. writing, eating, work, independence) and what risks feel tolerable. (4) For psychiatric trials: explore hopes and fears about personality or emotional change, how long benefit can take (Toronto OCD responses increased between one and two years), the chance of no benefit, and randomisation or sham arms where relevant. [source: FUS Foundation 2024 summary; Consultant Live 2026] (5) Check voluntariness: pressure from family, services, finances or despair. (6) Offer to help the client involve family if they wish. [source: NICE 2018] (7) Respect any decision, including "no" or "not yet".
• Example language (illustrative): "If it helped half as much as you hope, would it still feel worth it?" / "Some people feel they have to say yes because everything else has failed. Is any of that true for you?"
• Watch for: fluctuating capacity during severe depression or OCD crises (raise with the team; capacity is assessed by them and, under s57, by appointed certifiers); you becoming an advocate for or against the procedure. Working: the client can state the main benefit, main risks, permanence and alternatives in their own words.

B4. Baseline psychological assessment shared with the team

• Purpose: a clear picture before the procedure so later changes can be noticed.
• Steps: (1) Record current mood, anxiety, sleep, suicidality, substance use, cognition in daily life, relationships and functioning. (2) Use validated measures you are licensed to use; trials use their own scales (e.g. Y-BOCS, HAMD-17; mood and anxiety inventories in tremor studies) administered by the research team. [source: FUS Foundation 2024 summary; Saporito et al. 2024] (3) Ask the client's consent to share a summary with the team and agree what you will pass on later. (4) Flag any substance misuse to the team via the client, since signs of alcohol or substance misuse are listed as an exclusion. [source: FUS Foundation 2016]
• Example language (illustrative): "I'd like a snapshot of how things are now, so that if anything shifts after the procedure we'll both notice. Is it alright if I send a short summary to your team?"
• Watch for: clients minimising symptoms to stay eligible. Working: a dated baseline exists in your notes and, with consent, with the team.

B5. Preparing for procedure day

• Purpose: reduce anticipatory anxiety about being awake in an MRI scanner with a head frame for a long time.
• Steps: (1) Ask the team (via the client) what the day involves at their centre. (2) Rehearse coping skills the client already uses: paced breathing, grounding, attention shifting, self-statements. (3) Address claustrophobia or fear of loss of control; encourage the client to tell the team beforehand. (4) Plan for practicalities and support afterwards (travel, someone at home). (5) Plan how the client will handle a result that falls short on the day.
• Example language (illustrative): "You'll be awake and they'll be asking you to do things. What helps you stay steady when you can't move much?"
• Watch for: severe claustrophobia or panic that could stop the client lying still (the inability to lie still for a prolonged procedure is listed as an exclusion; this is for the team to judge). [source: FUS Foundation 2016]

B6. Monitoring and passing on changes after treatment

• Purpose: notice and pass on mood, behavioural, cognitive or physical changes to the treating team.
• Steps: (1) Brief check-ins in the first weeks, then at your usual rhythm. (2) Compare with baseline: mood, anxiety, apathy, sleep, irritability, impulsivity, memory or concentration in daily life, suicidal thoughts. (3) Ask about listed effects (numbness, unsteadiness, gait problems, headache) and their emotional impact. [source: FUS Foundation 2016] (4) For low-intensity stimulation trials, ask about activation or agitation (increased excitability has been reported). [source: Consultant Live 2026] (5) Pass on new or worsening symptoms to the team the same day if urgent, otherwise at the agreed point, with the client's knowledge. (6) Urgent signs of a medical emergency (e.g. sudden severe headache, new weakness, confusion) go to emergency services.
• Example language (illustrative): "You mentioned feeling flat since the procedure. That's worth your team knowing about. Shall we call them together, or would you rather I write?"
• Watch for: attributing everything to the procedure or to nothing; group-level studies showing stable or improved mood do not rule out individual change. [source: Saporito et al. 2024] Working: changes reach the team promptly.

B7. Crisis and safety planning

• Purpose: protect clients at higher risk around the procedure, especially psychiatric trial participants and clients who may be disappointed.
• Steps: (1) Before the procedure, write a safety plan with warning signs, coping steps, people, professional contacts including the trial team, and emergency numbers. (2) Explicitly plan for non-response or slow response (benefit after capsulotomy may take a year or more). [source: FUS Foundation 2024 summary] (3) Discuss means safety in the usual way (secure storage or removal of means). (4) Review risk at each post-procedure contact. (5) Agree with the client which risk information you will share with the team.
• Example language (illustrative): "If the first months don't bring the change you're hoping for, what might you start telling yourself? Let's plan for that now."
• Watch for: hopelessness after a "last resort" fails. Working: the client knows what to do and whom to call.

B8. Integrating psychotherapy before, during and after

• Purpose: keep psychological treatment part of the plan.
• Steps: (1) For tremor: adjustment to changed function and body image, return to valued activities that tremor had blocked, social anxiety about residual tremor, grief if the result is partial; collaborate with physiotherapy if balance is affected. (2) For psychiatric trial participants: agree with the trial team, before the procedure, when and how evidence-based therapy (e.g. exposure and response prevention for OCD, behavioural activation or CBT for depression) will resume, and check any trial restrictions on concurrent therapy. (3) Help clients use any reduction in symptoms to rebuild routines and roles. (4) Revisit identity and meaning: life after decades of illness.
• Example language (illustrative): "If the urges ease even a bit, that's the moment exposure work can move faster. Shall we plan for that?"
• Watch for: expecting the procedure to do all the work. Working: functional gains, not only scale scores.

B9. Support after treatment ends and long-term follow-up

• Purpose: consolidate gains and keep links with the team.
• Steps: (1) Encourage attendance at all follow-up (NICE emphasises regular checks; trials and Victorian law require long follow-up). [source: NICE 2018; FUS Foundation 2024 summary; Victoria Department of Health] (2) Relapse-prevention plan. (3) For essential tremor, support decision-making about a second side if it arises, routed to the team. [source: NeurologyLive 2022] (4) Plan ending or tapering of therapy contact.
• Example language (illustrative): "Your team will want to see you at set points. What gets in the way of going?"
• Watch for: drop-out from follow-up (the commonest reason for drop-out in one study was distance). [source: Saporito et al. 2024]

B10. Responding to unregulated or do-it-yourself offers

• Purpose: protect clients from stimulation outside regulated care.
• Steps: (1) Ask non-judgementally what was offered and by whom. (2) Point out that psychiatric uses are investigational and available only in trials as of October 2026. [source: FUS Foundation OCD page] (3) Suggest checking trial registries and asking their psychiatrist. (4) Advise against home or DIY brain-stimulation devices; the documented risks of DIY stimulation are covered in the neuromodulation tabs of this family. [uncertain]
• Example language (illustrative): "If this were available outside studies, your psychiatrist would know about it. Shall we ask them together?"
• Watch for: offers outside trials, high up-front fees, or claims of a cure. Working: the client checks registries and raises the offer with the psychiatrist before deciding. [synthesis]

5. Handling problems

The sources do not address the therapist's role; everything in this section is [synthesis] unless tagged.

• Client set on the procedure as a cure. Slow down: review the listed risks, the permanence, NICE's note on long-term uncertainty, and the realistic chance of partial benefit. [source: NICE 2018; FUS Foundation 2016] Ask what life would look like if symptoms halved rather than vanished.
• Client refuses to consider it out of fear. Validate; separate accurate risks from catastrophic images (e.g. "brain surgery" imagery); remind them that declining is a legitimate option NICE lists. [source: NICE 2018] Do not push.
• Ambivalence after being accepted. Normal. Use decisional-balance work, keep the team informed via the client, and remind them that the decision can be postponed until the day. Never advise them to proceed or withdraw.
• Desperation in refractory OCD or depression. Treat hopelessness as a clinical target in its own right; review suicide risk; check whether adequate evidence-based therapy (including intensive or residential options) has been tried; make clear that capsulotomy is research only. [source: FUS Foundation OCD page]
• Concerns about capacity or coercion. Do not judge capacity alone: share specific observations with the treating psychiatrist or team. Remember that frameworks such as s57 (England and Wales) and Victoria's Tribunal process require the person's own consent; substitute consent is excluded in Victoria. [source: s57 text; Victoria Department of Health]
• Anxiety or panic on the day / claustrophobia. Plan in advance (B5); ensure the team knows; afterwards, process the experience.
• Disappointment or partial benefit. Normalise mixed outcomes; grieve the hoped-for result; problem-solve function with what improved; route questions about further procedures (second side, other options) to the team. For psychiatric trials, remember OCD benefit grew between one and two years in the Toronto studies, but do not promise it. [source: FUS Foundation 2024 summary; NeurologyLive 2022]
• New side effects (numbness, unsteadiness, gait problems). Pass on to the team; support adjustment and fall-related anxiety; collaborate with physiotherapy or occupational therapy if involved. [source for side effects: FUS Foundation 2016]
• New mood, personality, motivation or behaviour changes. Do not interpret them yourself. Record, compare with baseline, and pass on promptly; involve family observations with consent. Published group data on tremor patients show stable or improved mood and cognition, but individuals vary, and detailed psychiatric adverse-effect data for focused-ultrasound capsulotomy are not covered here. [source: Saporito et al. 2024] [uncertain]
• Activation or agitation in a low-intensity trial. Increased excitability has been reported in a trial; pass on to the research team the same day, and review sleep and risk. [source: Consultant Live 2026]
• Non-adherence to follow-up. Explore barriers (distance was the commonest drop-out reason in one study); help plan travel or remote follow-up options with the team. [source: Saporito et al. 2024]
• Rupture: client feels you were against (or for) the procedure. Acknowledge; restate your neutral role (helping them decide and cope, not deciding for them); repair before continuing.
• Family conflict about the decision. Offer a joint session, focusing on the client's values and the information from the team; family can be involved if the patient wishes. [source: NICE 2018]
• Client wants stimulation outside regulated care or online. See B10; check trial registries together; raise with their psychiatrist.
• Uncertain legal status of a planned psychiatric procedure. Ask the treating team which legal safeguards apply (e.g. whether s57 certification is required in England and Wales); do not offer legal opinions. [uncertain]

Sources

Sources:

• FDA approves first MRI-guided focused ultrasound device to treat essential tremor — Focused Ultrasound Foundation, 2016.
• FDA Approval for Parkinson's Disease — Focused Ultrasound Foundation timeline.
• Insightec announces FDA approval of staged bilateral focused ultrasound treatment for Parkinson's disease — Insightec, 8 July 2025.
• FDA approves Insightec Exablate Neuro to treat second side essential tremor — NeurologyLive, December 2022.
• Unilateral MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor (patient information) — NICE, 20 June 2018.
• Obsessive-Compulsive Disorder (OCD) — Focused Ultrasound Foundation, accessed October 2026.
• Long-term clinical results: focused ultrasound safe and effective for OCD and depression — Focused Ultrasound Foundation summary of Lipsman and colleagues, Biological Psychiatry (year not stated on page) [uncertain].
• Sonication-based OCD Neurosurgical Intervention Via Capsulotomy (NCT06131502) — ClinicalTrials.gov; record did not render, title only.
• Cognitive safety of focused ultrasound thalamotomy for tremor: 1-year follow-up results of the COGNIFUS part 2 study — Saporito G, Sucapane P, et al., Frontiers in Neurology 2024;15:1395282.
• Transcranial Focused Ultrasound Neuromodulation in Psychiatry: Main Characteristics, Current Evidence, and Future Directions — Keihani A, et al., Brain Sciences 2024;14(11):1095 (abstract record).
• Low-intensity ultrasound brain stimulation safely reduces depression symptoms — Consultant Live, 7 January 2026, reporting Cai X, et al., J Affect Disord 2026;394(Pt B):120666.
• Mental Health Act 1983 section 57 text — mentalhealthlaw.co.uk.
• Neurosurgery for mental illness — Victoria Department of Health, Mental Health and Wellbeing Act handbook.

Further reading (not drawn on; titles only): ClinicalTrials.gov NCT07113665 (MRgFUS bilateral capsulotomy for refractory anorexia nervosa with comorbid OCD or MDD) and NCT03156335 (MRgFUS bilateral capsulotomy for refractory OCD); the FDA labelling and Summary of Safety and Effectiveness Data for Exablate Neuro; EU, MHRA and other national regulatory listings. [uncertain]

Related tabs: 029 Stereotactic psychosurgery (ablative and stimulation psychiatric neurosurgery, consent frameworks); Domain XVI (history and harms of lobotomy).