Obsessive-Compulsive DisorderPhase 1/2SONICNCT06131502
Sonication-based OCD Neurosurgical Intervention Via Capsulotomy
A Phase 1/2 study testing ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy in people with Obsessive-Compulsive Disorder, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The goal of this clinical trial is to determine if ExAblate MR-guided Focused Ultrasound (MRgFUS) bilateral anterior capsulotomy can be used safely and effectively to relieve symptoms of moderate to severe obsessive compulsive disorder (OCD) in individuals who have not benefited from psychotherapy and medications. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2026to Aug 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 25-64 years, inclusive.
- Patients who are able and willing to give consent and able to attend study visits, as determined by both study psychiatrist and the surgeon.
- DSM-5 diagnosis of Obsessive-Compulsive Disorder (OCD), at least 5-year illness history, with a minimum score of 28 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for stage I and a minimum score of 24 on Y-BOCS for stage II.
- Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by psychiatrists associated with the study. Including specifically:
- Failed adequate trial of three or more medications accepted as first line in the treatment of OCD such as selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine, citalopram), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs, e.g. clomipramine) or other antidepressants at the maximal tolerated dose. Adequate maximal doses and minimal duration of these medication are listed in Table 2 below.
- Attempted augmentation, if tolerated, by at least two medications known to be second line treatments for OCD such as clonazepam, haloperidol, risperidone, olanzapine, gabapentin.
Show all 10Show fewer
- An adequate trial of cognitive behavioral therapy (CBT) delivered by a therapist experienced in treating OCD. Criteria for an adequate CBT are listed in Table 3 below.
- In stage II patients that cannot tolerate pharmacotherapy or participate in psychotherapy will be included in the study.
- A consistent dose of all medications in the 30 days prior to study entry
- Able to communicate sensations during the ExAblate MRgFUS treatment
Who cannot join
- Presence of significant cognitive impairment (as measured by a score <25 on the mini-mental state examination, MMSE)
- Lifetime diagnosis of psychosis or bipolar disorder or presence of suicidality (as measured by a score >=2, item 9 of the BDI or high suicidal risk measured by the Columbia Suicide Severity Rating Scale (C-SSRS)). Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 3 months prior to study entry and if deemed appropriately managed by the site psychiatrist.
- DSM-5 diagnosis of substance use disorder (SUD) within the past 6 months
- Patients with unstable cardiac status [e.g. unstable angina pectoris on medication; patients' medication (other than diuretic); patients on anti-arrhythmic drugs; severe hypertension (diastolic BP > 100 on medication)]
- Cerebrovascular disease (e.g. CVA within 6 months), history of intracranial hemorrhage or intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
- Untreated, uncontrolled sleep apnea
Show all 20Show fewer
- Patients with brain tumors, epilepsy, neurodegenerative disease or any other major neurological disorder
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner
- An Overall Skull Density Ratio of less than 0.40 as calculated from the screening CT
- Severely impaired renal function (estimated glomerular filtration rate < 30ml/min/1.73 m2) or receiving dialysis
- Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)
- Current medical condition resulting in abnormal bleeding and/or coagulopathy.
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure. Receiving medications or supplements that increase the risk of bleeding such as NSAIDS, Ginko Baloba and Ginseng within one week of focused ultrasound procedure.
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Patients unable to communicate with the investigator and staff
- Currently pregnant (as determined by history and serum HCG) or lactating
- Life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, liver failure, blood dyscrasias, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Stanford University
Palo Alto, California, 94305
Bhati Mahendra, MD, mbhati@stanford.edu
About this study
Official title: ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy for Treatment of Obsessive-Compulsive Disorder
The goal of this clinical trial is to determine if ExAblate MR-guided Focused Ultrasound (MRgFUS) bilateral anterior capsulotomy can be used safely and effectively to relieve symptoms of moderate to severe obsessive compulsive disorder (OCD) in individuals who have not benefited from psychotherapy and medications.
The main questions it aims to answer are:
Read more
- Can ExAblate MRgFUS capsulotomy be safely delivered to individuals suffering from treatment-refractory OCD through an intact skull with a risk and side-effect profile that is comparable to other neurosurgical approaches for capsulotomy?
- Will ExAblate MRgFUS capsulotomy result in improvement in clinical symptoms and quality of life metrics that are similar to those seen with other surgical approaches for capsulotomy?
In the first stage of the study, participants with severe, treatment resistant OCD (n=10) will be recruited in two centers (Harvard and Stanford) and treated with best medical care (BMT) for 6 months. Thereafter, they will receive the ExAblate MRgFUS procedure and then another BMT for 12 months. In the second stage of the study, participants with moderate to severe OCD (n=56) will be recruited in a multi-center study and treated with BMT plus real or sham MRgFUS for 12 months. Thereafter, those who received sham MRgFUS and did not improve will receive real MRgFUS and then treated with BMT for another 12 months.
Read the detailed description
The proposed study aims to establish the safety and efficacy of ExAblate MR-guided Focused Ultrasound (MRgFUS) for patients with treatment-refractory obsessive-compulsive disorder (OCD). Bilateral anterior thermo-capsulotomy and gamma-knife capsulotomy are well-known and effective treatments for treatment-refractory OCD patients. In this study, the investigators will use the ExAblate MRgFUS technology (Insightec Ltd) as a new method for capsulotomy for OCD patients. The ExAblate MRgFUS technology for neuro-related clinical applications has received FDA approval for Essential Tremor. In addition, the FDA approved an expansion of the ExAblate Neuro to include the treatment of tremor-dominant Parkinson's Disease. The study is designed to demonstrate safety and effectiveness and intended as a primary clinical support for a future marketing application.
The investigators propose a two-stage research protocol to establish the safety and efficacy of ExAblate MRgFUS for patients with treatment-resistant OCD. The first stage will be designed as a 'patient as own control' paradigm. Severe, treatment resistant OCD patients (n=10) will be recruited in two centers (Harvard and Stanford) and treated for 6 months by a best medical treatment (BMT) protocol followed by the ExAblate MRgFUS procedure plus BMT for another 12 months. The second stage will be designed as a 'double blind randomized control trial' paradigm. Moderate to severe, partially treatment resistant OCD patients (n=56) will be recruited in a multi-centered study and randomized into the ExAblate MRgFUS or sham procedures. They will be treated by BMT plus MRgFUS or BMT plus sham for 12 months followed by BMT plus the Exablate MRgFUS for the non-responding sham group for another 12 months.
This study is the first to evaluate ExAblate MRgFUS for OCD in the USA. This protocol was developed by two collaborating centers at Harvard and Stanford Universities, with two experienced and dedicated multidisciplinary teams of psychiatrists, neurosurgeons, psychologists, radiologists and neurologists. The suggested technical protocol using the ExAblate MRgFUS system for OCD is derived from a reported Korean study and an on-going Canadian clinical study.
The study is funded by the Focused Ultrasound Foundation and Insightec Ltd.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy
- Keywords
- OCD, neuroimaging, neurosurgery, MR-guided focused ultrasound (MRgFUS), Capsulotomy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MR-guided Focused Ultrasound Bilateral Anterior CapsulotomyDevice
The ExAblate transcranial system combines a focused ultrasound surgery delivery system and a conventional diagnostic 3T MRI scanner. The ExAblate transcranial system provides real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control.
| Study group | Role | What they receive |
|---|---|---|
| Active FUS | Active comparator | The treatment volume and plan will be defined by the neurosurgeon. The ExAblate MRgFUS system will automatically compute the number of sonications, and the (per sonication spot) phase and amplitude corrections necessary for the system to produce a focal spot at each of the desired locations. The target selected for this study is the anterior limb of the internal capsule (ALIC). The target will be approximately 7-10mm rostral to the anterior edge of the anterior commissure, in the ventral part of the ALIC. A central point in the targeted area will be targeted with a low dose, sub-lethal energy level sonication to confirm the targeting accuracy on the MR images. Focal point position and/or transducer location will be adjusted as necessary. Receives: Device: ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy |
| Sham FUS | Sham comparator | The sham procedure will be identical in planning and execution to the ExAblate procedure with the only exception being that the energy output will be 0 for the sham-treated subjects. To perform the sham treatment, the sonication will be performed with energy output disabled. For sham subjects, the physician will interact with a subject in a similar manner and for a similar duration to simulate an actual procedure. When possible, the treating physician may determine a sonication (treatment) time for sham subjects to be similar to that which is occurring in the ExAblate procedure to maintain consistency between treatment arms. It should be noted that all treatment times of both treatment arms will be captured in the study CRF. Receives: Device: ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Assesses the clinical severity of obsessive-compulsive symptoms (OCD). Higher scores indicate greater severity of OCD symptoms.
Primary effectiveness will be evaluated using validated scores; the Y-BOCS score for the OCD patients, based upon patients where bilateral ExAblate capsulotomy was attempted (i.e., intent-to- treat analysis). Efficacy is defined as a reduction of 35% of pre-treatment Y-BOCS score at 12- months post-treatment.
Measured: 12 months
Phase I: Evaluation of the incidence and severity of procedure related complications
Subjective assessment of safety. The adverse event profile and improvement in Y-BOCS during the 6 months period of BMT will be compared to the adverse event profile and improvement in Y- BOCS during the next 12 months period of ExAblate MRgFUS capsulotomy plus BMT. Success is defined as at least 35% reduction in Y-BOCS in 33% of patients.
Measured: 12 months
Secondary outcomes (7)
Phase I: Clinical Global Impression (CGI) scale
Clinician-rated tool to measure perspective of a patient's global functioning, severity of illness, and treatment response
Measured: 12 months
Phase I: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
36-item functional assessment (each question rated 1-5) Minimum: 36 Maximum: 180 Can also be scored by percentiles Higher score indicates more disability
Measured: 12 months
Phase I: Hamilton Rating Scale for Depression (HAM-D)
17-item, clinician-administered tool to measure the severity of depressive symptoms. Scores range from 0-52, a higher score indicating more severe depression.
Measured: 12 months
Phase I: Hamilton Rating Scale for Anxiety (HAM-A)
14-item, clinician-administered tool to measure the severity of anxiety symptoms. Scores ranging from 0-56, where higher scores indicate greater severity.
Measured: 12 months
Phase I: Beck Depression Inventory (BDI)
Depression severity rating scales (0-63, higher numbers indicate higher severity)
Measured: 12 months
Phase I: Beck Anxiety Inventory (BAI)
Anxiety severity rating scale (0-63, higher numbers indicate higher severity)
Measured: 12 months
Phase I: Quality-of-Life Enjoyment and Satisfaction Questionnaire (QLESQ)
16-item self-report tool that measures satisfaction with various life domains (physical health, mood, social relationships, etc). Higher scores indicate better life satisfaction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study startAug 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In the first stage of the study, participants with severe, treatment resistant OCD (n=10) will be recruited in two centers (Harvard and Stanford) and treated with best medical care (BMT) for 6 months. Thereafter, they will receive the ExAblate MRgFUS procedure and then another BMT for 12 months. In the second stage of the study, participants with moderate to severe OCD (n=56) will be recruited in a multi-center study and treated with BMT plus real or sham MRgFUS for 12 months. Thereafter, those who received sham MRgFUS and did not improve will receive real MRgFUS and then treated with BMT for another 12 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Joseph J. Taylor, MD, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131502
- Sponsor's protocol ID
- 2025P003340
- Acronym
- SONIC
- Status last verified
- Oct 2025
- First submitted
- 9 Nov 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy for Treatment of Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06131502
- Acronym / sponsor ID
- SONIC / 2025P003340
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, neuroimaging, neurosurgery, MR-guided focused ultrasound (MRgFUS), Capsulotomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine if ExAblate MR-guided Focused Ultrasound (MRgFUS) bilateral anterior capsulotomy can be used safely and effectively to relieve symptoms of moderate to severe obsessive compulsive disorder (OCD) in individuals who have not benefited from psychotherapy and medications.
The main questions it aims to answer are:
- Can ExAblate MRgFUS capsulotomy be safely delivered to individuals suffering from treatment-refractory OCD through an intact skull with a risk and side-effect profile that is comparable to other neurosurgical approaches for capsulotomy?
- Will ExAblate MRgFUS capsulotomy result in improvement in clinical symptoms and quality of life metrics that are similar to those seen with other surgical approaches for capsulotomy?
In the first stage of the study, participants with severe, treatment resistant OCD (n=10) will be recruited in two centers (Harvard and Stanford) and treated with best medical care (BMT) for 6 months. Thereafter, they will receive the ExAblate MRgFUS procedure and then another BMT for 12 months. In the second stage of the study, participants with moderate to severe OCD (n=56) will be recruited in a multi-center study and treated with BMT plus real or sham MRgFUS for 12 months. Thereafter, those who received sham MRgFUS and did not improve will receive real MRgFUS and then treated with BMT for another 12 months.
Detailed description
The proposed study aims to establish the safety and efficacy of ExAblate MR-guided Focused Ultrasound (MRgFUS) for patients with treatment-refractory obsessive-compulsive disorder (OCD). Bilateral anterior thermo-capsulotomy and gamma-knife capsulotomy are well-known and effective treatments for treatment-refractory OCD patients. In this study, the investigators will use the ExAblate MRgFUS technology (Insightec Ltd) as a new method for capsulotomy for OCD patients. The ExAblate MRgFUS technology for neuro-related clinical applications has received FDA approval for Essential Tremor. In addition, the FDA approved an expansion of the ExAblate Neuro to include the treatment of tremor-dominant Parkinson's Disease. The study is designed to demonstrate safety and effectiveness and intended as a primary clinical support for a future marketing application.
The investigators propose a two-stage research protocol to establish the safety and efficacy of ExAblate MRgFUS for patients with treatment-resistant OCD. The first stage will be designed as a 'patient as own control' paradigm. Severe, treatment resistant OCD patients (n=10) will be recruited in two centers (Harvard and Stanford) and treated for 6 months by a best medical treatment (BMT) protocol followed by the ExAblate MRgFUS procedure plus BMT for another 12 months. The second stage will be designed as a 'double blind randomized control trial' paradigm. Moderate to severe, partially treatment resistant OCD patients (n=56) will be recruited in a multi-centered study and randomized into the ExAblate MRgFUS or sham procedures. They will be treated by BMT plus MRgFUS or BMT plus sham for 12 months followed by BMT plus the Exablate MRgFUS for the non-responding sham group for another 12 months.
This study is the first to evaluate ExAblate MRgFUS for OCD in the USA. This protocol was developed by two collaborating centers at Harvard and Stanford Universities, with two experienced and dedicated multidisciplinary teams of psychiatrists, neurosurgeons, psychologists, radiologists and neurologists. The suggested technical protocol using the ExAblate MRgFUS system for OCD is derived from a reported Korean study and an on-going Canadian clinical study.
The study is funded by the Focused Ultrasound Foundation and Insightec Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In the first stage of the study, participants with severe, treatment resistant OCD (n=10) will be recruited in two centers (Harvard and Stanford) and treated with best medical care (BMT) for 6 months. Thereafter, they will receive the ExAblate MRgFUS procedure and then another BMT for 12 months. In the second stage of the study, participants with moderate to severe OCD (n=56) will be recruited in a multi-center study and treated with BMT plus real or sham MRgFUS for 12 months. Thereafter, those who received sham MRgFUS and did not improve will receive real MRgFUS and then treated with BMT for another 12 months.
| Arm | Type | Receives |
|---|---|---|
| Active FUS | Active comparator | Device: ExAblate MR-guided Focused Ultrasound Bilateral Anterior CapsulotomyThe treatment volume and plan will be defined by the neurosurgeon. The ExAblate MRgFUS system will automatically compute the number of sonications, and the (per sonication spot) phase and amplitude corrections necessary for the system to produce a focal spot at each of the desired locations. The target selected for this study is the anterior limb of the internal capsule (ALIC). The target will be approximately 7-10mm rostral to the anterior edge of the anterior commissure, in the ventral part of the ALIC. A central point in the targeted area will be targeted with a low dose, sub-lethal energy level sonication to confirm the targeting accuracy on the MR images. Focal point position and/or transducer location will be adjusted as necessary. |
| Sham FUS | Sham comparator | Device: ExAblate MR-guided Focused Ultrasound Bilateral Anterior CapsulotomyThe sham procedure will be identical in planning and execution to the ExAblate procedure with the only exception being that the energy output will be 0 for the sham-treated subjects. To perform the sham treatment, the sonication will be performed with energy output disabled. For sham subjects, the physician will interact with a subject in a similar manner and for a similar duration to simulate an actual procedure. When possible, the treating physician may determine a sonication (treatment) time for sham subjects to be similar to that which is occurring in the ExAblate procedure to maintain consistency between treatment arms. It should be noted that all treatment times of both treatment arms will be captured in the study CRF. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 25-64 years, inclusive.
- Patients who are able and willing to give consent and able to attend study visits, as determined by both study psychiatrist and the surgeon.
- DSM-5 diagnosis of Obsessive-Compulsive Disorder (OCD), at least 5-year illness history, with a minimum score of 28 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for stage I and a minimum score of 24 on Y-BOCS for stage II.
- Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by psychiatrists associated with the study. Including specifically:
- A consistent dose of all medications in the 30 days prior to study entry
Key exclusion criteria (20 listed)
- Presence of significant cognitive impairment (as measured by a score <25 on the mini-mental state examination, MMSE)
- Lifetime diagnosis of psychosis or bipolar disorder or presence of suicidality (as measured by a score >=2, item 9 of the BDI or high suicidal risk measured by the Columbia Suicide Severity Rating Scale (C-SSRS)). Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 3 months prior to study entry and if deemed appropriately managed by the site psychiatrist.
- DSM-5 diagnosis of substance use disorder (SUD) within the past 6 months
- Patients with unstable cardiac status [e.g. unstable angina pectoris on medication; patients' medication (other than diuretic); patients on anti-arrhythmic drugs; severe hypertension (diastolic BP > 100 on medication)]
- Cerebrovascular disease (e.g. CVA within 6 months), history of intracranial hemorrhage or intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate MR-guided Focused Ultrasound Bilateral Anterior CapsulotomyThe ExAblate transcranial system combines a focused ultrasound surgery delivery system and a conventional diagnostic 3T MRI scanner. The ExAblate transcranial system provides real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control. | Device | Active FUS, Sham FUS |
Primary outcome
Phase I: Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: 12 months
Assesses the clinical severity of obsessive-compulsive symptoms (OCD). Higher scores indicate greater severity of OCD symptoms. Primary effectiveness will be evaluated using validated scores; the Y-BOCS score for the OCD patients, based upon patients where bilateral ExAblate capsulotomy was attempted (i.e., intent-to- treat analysis). Efficacy is defined as a reduction of 35% of pre-treatment Y-BOCS score at 12- months post-treatment.
Phase I: Evaluation of the incidence and severity of procedure related complications
Time frame: 12 months
Subjective assessment of safety. The adverse event profile and improvement in Y-BOCS during the 6 months period of BMT will be compared to the adverse event profile and improvement in Y- BOCS during the next 12 months period of ExAblate MRgFUS capsulotomy plus BMT. Success is defined as at least 35% reduction in Y-BOCS in 33% of patients.
7 secondary outcomes
Phase I: Clinical Global Impression (CGI) scale
Time frame: 12 months
Phase I: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 12 months
Phase I: Hamilton Rating Scale for Depression (HAM-D)
Time frame: 12 months
Phase I: Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: 12 months
Phase I: Beck Depression Inventory (BDI)
Time frame: 12 months
Phase I: Beck Anxiety Inventory (BAI)
Time frame: 12 months
Phase I: Quality-of-Life Enjoyment and Satisfaction Questionnaire (QLESQ)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy in people with Obsessive-Compulsive Disorder, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Yale-Brown Obsessive-Compulsive Scale (YBOCS) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.