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Procedure

Focused Ultrasound Capsulotomy for Obsessive-Compulsive Disorder (SONIC Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 25-64 years

Medication-refractoriness as determined by adequate dose and duration of standard psychiatric treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial will study if ExAblate MRgFUS can safely and effectively treat individuals with OCD who have not benefited from psychotherapy and medications.

Who is the study for?

This trial is for adults aged 25-64 with moderate to severe OCD who haven't improved after therapy and at least three different medications. They must have had OCD for over five years, be able to give consent, attend visits, communicate during treatment, and meet certain symptom severity scores.

What is being tested?

The study tests if ExAblate MR-guided Focused Ultrasound can safely relieve severe OCD symptoms compared to other neurosurgical methods. Participants will first receive best medical care then the ultrasound procedure or a sham treatment followed by more care.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from the device's application, headache or dizziness post-procedure, localized pain or bruising where treated, and risks associated with any surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 64 years old.

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My mental health condition hasn't improved despite taking standard treatments.

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I have tried three or more medications for OCD without success.

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I have tried at least two medications for my OCD without success.

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I can communicate how I feel during the MRgFUS treatment.

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My OCD severity score is at least 28 for stage I or at least 24 for stage II.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Yale-Brown Obsessive-Compulsive Scale (YBOCS)

Secondary study objectives

Beck Anxiety Inventory (BAI)

Beck Depression Inventory (BDI)

Evaluation of the incidence and severity of procedure related complications

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Real FUSActive Control1 Intervention

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.

Group II: Sham FUSPlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met