Obsessive-Compulsive Disorder (OCD)NCT06816511
Preliminary Explorative Study of Magnetic Resonance-Guided Focused Ultrasound Surgery in Refractory Obsessive-Compulsive Disorder Patients
A study testing magnetic resonance-guided focused ultrasound surgery, MRgFUS in people with Obsessive-Compulsive Disorder (OCD), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate If magnetic resonance-guided focused ultrasound works to treat refractory obsessive-compulsive disorder in adults. The main questions it aims to answer are: What effectiveness does the magnetic resonance-guided focused ultrasound bring to the participants during study… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- magnetic resonance-guided focused ultrasound surgery, MRgFUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 12 Jul 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For 30 days before enrollment, the type and dosage of primary OCD medications (including antidepressants and adjunctive medications such as antipsychotics and tricyclic antidepressants) remain unchanged. However, other symptom-relief medications, such as anti-anxiety drugs, are not restricted.
- Diagnosed by a psychiatrist through a diagnostic interview, meeting the criteria for OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least five years; and scoring above 28 on the Chinese version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
- OCD symptoms show limited improvement with existing treatments, classified as refractory according to the OCD Clinical Practice Review Task Force of the Anxiety \& Depression Association of America (ADAA):
- Received treatment with at least three different antidepressants at adequate doses and durations.
- Received treatment with at least two of the following medications for over a month each: antipsychotics, clonazepam, lithium, buspirone.
- Underwent appropriate cognitive-behavioral therapy with exposure and response prevention (EX/RP) for at least 20 sessions.
- Able to comply with focused ultrasound-related operational instructions (device: ExAblate MRgFUS). During the procedure, participants must be able to communicate with the physician and express their sensory experiences (general anesthesia is not required).
- After explanation by a psychiatrist and neurosurgeon, participants provide informed consent and can comply with the research process and related guidance. During the trial, participants must be able to independently press the stop-ultrasound button.
Who cannot join
- Major and Potential Physical Conditions That May Affect the Treatment Process: i. Cardiovascular or hemodynamic abnormalities, such as heart failure, arrhythmias, tachycardia or bradycardia (>100 bpm, <60 bpm), abnormal systolic blood pressure (>180 mmHg, <90 mmHg), abnormal diastolic blood pressure (>180 mmHg), and severe hypertension uncontrolled by medication (diastolic blood pressure >100 mmHg after stable medication use). Additionally, those who have taken medications affecting autonomic regulation and potentially impacting vital sign stability within six months before treatment (however, antidepressants and antipsychotics taken for mental illness are not included).
- Platelet or coagulation disorders or currently taking anticoagulant medications (e.g., Warfarin, Avastin).
- Renal dysfunction (eGFR < 30ml/min/1.73 m²) or currently undergoing hemodialysis.
- Severe infections. v. Immunocompromised individuals. vi. History of intracranial hemorrhage, intracranial aneurysm, cerebrovascular events within six months, or brain tumors.
- Neurological disorders: stroke, epilepsy, suspected increased intracranial pressure (IICP), Parkinson's disease and related disorders (Multisystem atrophy, Progressive supranuclear palsy, Dementia with Lewy bodies, Alzheimer's disease).
- Other clinically assessed physical conditions that may pose significant risks to bodily functions and life during the treatment process.
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- Patients deemed unsuitable for magnetic resonance-guided focused ultrasound after evaluation, including those with low skull density ratio (<0.4), intracranial implants, or structures that cannot avoid energy-absorbing or sensitive tissues in the ultrasound path (e.g., previous brain shunt sites, surgical metal clips, significant calcification, extensive scarring, or any rigid implants). (Pre-treatment evaluation will include a head CT scan to calculate the skull density ratio (SDR) to determine suitability for focused ultrasound treatment; a low SDR may affect the efficiency of the treatment and increase side effects, making the patient unsuitable for treatment.)
- Bilateral structural abnormalities in the anterior limb of the internal capsule (ALIC).
- Contraindications to MRI or its contrast agents, or incompatible metal implants in the body.
- Inability to comply with treatment instructions, lack of behavioral capacity, or lack of treatment motivation.
- Major psychiatric comorbidities: schizophrenia spectrum disorders, acute episodes, bipolar disorder, acute episodes, severe dementia, unresolved alcohol or substance abuse, recent suicidal ideation or plans.
- Pregnancy or breastfeeding.
- Scalp atrophy or difficulty healing scalp wounds.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to evaluate If magnetic resonance-guided focused ultrasound works to treat refractory obsessive-compulsive disorder in adults. The main questions it aims to answer are:
- What effectiveness does the magnetic resonance-guided focused ultrasound bring to the participants during study period?
- What side effects do the participant have when treated with magnetic resonance-guide focused ultrasound?
Participants will:
- Finish scales to evaluate participants' level of cognitive function, depression and Compulsiveness.
- Receive the treatment of magnetic resonance-guided focused ultrasound
- Take the fMRI brain scanning before and after the treatment
- Recovering
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- magnetic resonance-guided focused ultrasound surgery, MRgFUS
- Keywords
- Magnetic Resonance-Guided Focused Ultrasound, Refractory Obsessive-Compulsive Disorder, anterior limb of the internal capsule, functional magnetic resonance imaging
- 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.
magnetic resonance-guided focused ultrasound surgery, MRgFUSProcedure or surgery
Magnetic Resonance-Guided Focused Ultrasound Surgery The clinical symptoms, brain imaging, and cognitive function status were followed up for 2 years before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Procedure: magnetic resonance-guided focused ultrasound surgery, MRgFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Measured: For two years after the surgery
Secondary outcomes (2)
Clinical Symptoms
Chinese version of the Yale-Brown Obsessive-Compulsive Scale, Chinese version of the Montgomery Depression Scale, Chinese version of the Hamilton Anxiety Scale.
Measured: For two years after the surgery
Structural Brain Imaging
Measured: For two years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jan 2024
- Primary completion12 Jul 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by National Taiwan University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816511
- Sponsor's protocol ID
- 202307078DIND
- Status last verified
- Jul 2026
- First submitted
- 26 Dec 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Explorative Study of Magnetic Resonance-Guided Focused Ultrasound Surgery in Refractory Obsessive-Compulsive Disorder Patients
- ClinicalTrials.gov ID
- NCT06816511
- Acronym / sponsor ID
- 202307078DIND
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Keywords
- Magnetic Resonance-Guided Focused Ultrasound, Refractory Obsessive-Compulsive Disorder, anterior limb of the internal capsule, functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 10 Feb 2025 (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 evaluate If magnetic resonance-guided focused ultrasound works to treat refractory obsessive-compulsive disorder in adults. The main questions it aims to answer are:
- What effectiveness does the magnetic resonance-guided focused ultrasound bring to the participants during study period?
- What side effects do the participant have when treated with magnetic resonance-guide focused ultrasound?
Participants will:
- Finish scales to evaluate participants' level of cognitive function, depression and Compulsiveness.
- Receive the treatment of magnetic resonance-guided focused ultrasound
- Take the fMRI brain scanning before and after the treatment
- Recovering
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: magnetic resonance-guided focused ultrasound surgery, MRgFUS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For 30 days before enrollment, the type and dosage of primary OCD medications (including antidepressants and adjunctive medications such as antipsychotics and tricyclic antidepressants) remain unchanged. However, other symptom-relief medications, such as anti-anxiety drugs, are not restricted.
- Diagnosed by a psychiatrist through a diagnostic interview, meeting the criteria for OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least five years; and scoring above 28 on the Chinese version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
- OCD symptoms show limited improvement with existing treatments, classified as refractory according to the OCD Clinical Practice Review Task Force of the Anxiety \& Depression Association of America (ADAA):
- Received treatment with at least two of the following medications for over a month each: antipsychotics, clonazepam, lithium, buspirone.
- Underwent appropriate cognitive-behavioral therapy with exposure and response prevention (EX/RP) for at least 20 sessions.
Key exclusion criteria (13 listed)
- Major and Potential Physical Conditions That May Affect the Treatment Process: i. Cardiovascular or hemodynamic abnormalities, such as heart failure, arrhythmias, tachycardia or bradycardia (>100 bpm, <60 bpm), abnormal systolic blood pressure (>180 mmHg, <90 mmHg), abnormal diastolic blood pressure (>180 mmHg), and severe hypertension uncontrolled by medication (diastolic blood pressure >100 mmHg after stable medication use). Additionally, those who have taken medications affecting autonomic regulation and potentially impacting vital sign stability within six months before treatment (however, antidepressants and antipsychotics taken for mental illness are not included).
- Platelet or coagulation disorders or currently taking anticoagulant medications (e.g., Warfarin, Avastin).
- Renal dysfunction (eGFR < 30ml/min/1.73 m²) or currently undergoing hemodialysis.
- Severe infections. v. Immunocompromised individuals. vi. History of intracranial hemorrhage, intracranial aneurysm, cerebrovascular events within six months, or brain tumors.
- Neurological disorders: stroke, epilepsy, suspected increased intracranial pressure (IICP), Parkinson's disease and related disorders (Multisystem atrophy, Progressive supranuclear palsy, Dementia with Lewy bodies, Alzheimer's disease).
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 |
|---|---|---|
| magnetic resonance-guided focused ultrasound surgery, MRgFUSMagnetic Resonance-Guided Focused Ultrasound Surgery The clinical symptoms, brain imaging, and cognitive function status were followed up for 2 years before and after surgery. | Procedure or surgery | Experimental |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: For two years after the surgery
2 secondary outcomes
Clinical Symptoms
Time frame: For two years after the surgery
Structural Brain Imaging
Time frame: For two years after the surgery
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 31 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance-guided focused ultrasound surgery, MRgFUS in people with Obsessive-Compulsive Disorder (OCD), run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: For two years after the surgery). 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 31 Jul 2026.