Focused Ultrasound Capsulotomy for Obsessive-Compulsive Disorder

(SONIC Trial)

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Brigham and Women's Hospital

Must be taking: SSRIs, SNRIs, TCAs, others

Must not be taking: Anticoagulants, Antiplatelets, NSAIDs, others

Disqualifiers: Psychosis, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called ExAblate MR-guided Focused Ultrasound to determine if it can safely and effectively reduce symptoms of moderate to severe obsessive-compulsive disorder (OCD) in individuals who haven't found relief with therapy or medication. The study compares the safety and effectiveness of this ultrasound technique to other surgical approaches for OCD. Participants must have had OCD for at least five years and tried multiple treatments without success. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should have a consistent dose of all medications in the 30 days before joining the study. It also notes that certain medications that increase bleeding risk should be stopped within a week of the procedure.

What prior data suggests that ExAblate MR-guided Focused Ultrasound is safe for treating OCD?

Studies have shown that MR-guided Focused Ultrasound (MRgFUS) capsulotomy is a safe treatment for obsessive-compulsive disorder (OCD). Research indicates that patients tolerate this treatment well, with no serious side effects reported one year after treatment. Early results suggest that MRgFUS is effective for OCD, particularly in patients unresponsive to other treatments. While the safety data is encouraging, this treatment is still under study to confirm these results in larger populations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for OCD?

Researchers are excited about ExAblate MR-guided Focused Ultrasound for treating Obsessive-Compulsive Disorder (OCD) because it offers a non-invasive approach to targeting specific brain areas. Unlike traditional options like medication or cognitive-behavioral therapy, which can take time to work and may not be effective for everyone, this method uses precise ultrasound waves to focus on the anterior limb of the internal capsule in the brain. This precision could potentially offer quicker relief from symptoms with fewer side effects. Additionally, as it doesn't involve surgical incisions, it reduces recovery time and risks associated with invasive procedures. This innovative technique represents a promising shift in how we approach treatment for severe OCD cases.

What evidence suggests that ExAblate MR-guided Focused Ultrasound is effective for obsessive-compulsive disorder?

Research has shown that ExAblate MR-guided Focused Ultrasound (MRgFUS) capsulotomy can help treat obsessive-compulsive disorder (OCD). This trial will compare the effects of the real MRgFUS procedure with a sham procedure. The real MRgFUS targets a specific area of the brain and has improved OCD symptoms. One study found that MRgFUS capsulotomy was safe and effective one year after treatment, with participants experiencing significant relief from symptoms. Another study suggested it could be a promising option for those who haven't had success with other treatments. Overall, early evidence supports the potential of MRgFUS to help people with treatment-resistant OCD. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 25 and 64 years old.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Best Medical Treatment (BMT)

Participants with severe OCD receive best medical treatment for 6 months

6 months

ExAblate MRgFUS Procedure

Participants undergo the ExAblate MRgFUS procedure followed by BMT for 12 months

12 months

Sham or Real MRgFUS

Participants receive either real or sham MRgFUS with BMT for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ExAblate MR-guided Focused Ultrasound

Trial Overview 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.

How Is the Trial Designed?

Group I: Real FUS Active Control 1 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 FUS Placebo Group 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06816511

Preliminary Explorative Study of Magnetic Resonance- ... The goal of this clinical trial is to evaluate If magnetic resonance-guided focused ultrasound works to treat refractory obsessive-compulsive disorder in adults ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8057302/

Magnetic Resonance-Guided Focused Ultrasound Surgery for ... ... Magnetic Resonance-guided Focused Ultrasound ... Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01986296?tab=history&a=7

Record History | ver. 7: 2019-06-27 | NCT01986296 The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the ...

4. fusfoundation.org fusfoundation.org/posts/long-term-clinical-results-focused-ultrasound-safe-and-effective-for-obsessive-compulsive-disorder-ocd-depression/

Long-Term Clinical Results: Focused Ultrasound Safe and ... The group concluded that MRgFUS capsulotomy is safe in patients with OCD and MDD and particularly effective for OCD one year after treatment.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6158029/

A study of novel bilateral thermal capsulotomy with focused ... The results of this study indicate that bilateral thermal lesioning of the ALIC with MRgFUS may be an effective and safe approach for improving obsessive– ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03156335?term=focused%20ultrasound%20and%20Sunnybrook&viewType=Table&rank=8

Trial of MR-guided Focused Ultrasound (MRgFUS) ... The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory OCD. This study is designed as a prospective, ...

7. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-clinical-trial-begins-for-patients-with-obsessive-compulsive-disorder/

Focused Ultrasound Clinical Trial Begins for Patients with ... Researchers at Sunnybrook Health Sciences Centre in Toronto have begun a new clinical trial to evaluate the feasibility and safety of focused ultrasound.