Focused Ultrasound Capsulotomy for Obsessive-Compulsive Disorder

(SONIC Trial)

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

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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: 1. 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? 2. 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.

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 data supports the effectiveness of the treatment ExAblate MR-guided Focused Ultrasound for Obsessive-Compulsive Disorder?

Research shows that MR-guided focused ultrasound (MRgFUS) capsulotomy is a promising treatment for obsessive-compulsive disorder (OCD), with studies indicating it is safe and may lead to significant improvements in symptoms. In one study, 4 out of 6 patients with OCD showed a positive response, and the treatment was found to be more cost-effective and potentially safer than other surgical options. ^{1 2 3 4 5}

Is focused ultrasound capsulotomy safe for humans?

Focused ultrasound capsulotomy appears to be generally safe for humans, with studies showing no serious side effects. Some patients experienced minor issues like headaches and swelling, but overall, the procedure was well tolerated. ^{1 2 3 4 6}

How does the treatment ExAblate MR-guided Focused Ultrasound differ from other treatments for obsessive-compulsive disorder?

ExAblate MR-guided Focused Ultrasound is unique because it is a non-invasive treatment that uses focused ultrasound waves to create precise lesions in the brain without the need for surgery. This approach is different from traditional surgical methods as it does not require opening the skull, reducing the risk of surgery-related complications. ^{1 2 3 4 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Canada pubmed.ncbi.nlm.nih.gov

A study of novel bilateral thermal capsulotomy with focused ultrasound for treatment-refractory obsessive-compulsive disorder: 2-year follow-up. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

A study of novel bilateral thermal capsulotomy with focused ultrasound for treatment-refractory obsessive-compulsive disorder: 2-year follow-up. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound capsulotomy for refractory obsessive compulsive disorder and major depressive disorder: clinical and imaging results from two phase I trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Technical and radiographic considerations for magnetic resonance imaging-guided focused ultrasound capsulotomy. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

MR-Guided Focused Ultrasound Versus Radiofrequency Capsulotomy for Treatment-Refractory Obsessive-Compulsive Disorder: A Cost-Effectiveness Threshold Analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Bilateral thermal capsulotomy with MR-guided focused ultrasound for patients with treatment-refractory obsessive-compulsive disorder: a proof-of-concept study. [2018]