Focused Ultrasound for Bipolar Disorder

Overseen By Nir Lipsman, MD, PhD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Unstable cardiac, Coagulopathy, Psychosis, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new procedure called MR-guided focused ultrasound capsulotomy to determine its safety and effectiveness for people with treatment-resistant bipolar depression. The procedure uses focused sound waves to target and treat specific areas of the brain. It is intended for individuals who have tried at least two treatments for bipolar depression without success and are currently experiencing major depression. Researchers will monitor participants for 24 months to assess progress and any side effects.

As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research in bipolar depression treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not be on anticoagulant or antiplatelet therapy within one week of the procedure. It's best to discuss your specific medications with the trial team.

What prior data suggests that this MR-guided focused ultrasound capsulotomy is safe for treatment-resistant bipolar depression?

Research has shown that MR-guided focused ultrasound (MRgFUS) capsulotomy, which targets a specific part of the brain, has been studied for its safety in treating various conditions. In one study, participants who underwent this procedure experienced a noticeable reduction in symptoms, indicating it is generally well-tolerated.

Some studies have reported side effects like headaches and dizziness, but these were usually mild and temporary. However, as this is a newer treatment, research on its long-term safety continues. Potential participants should consult medical professionals to understand the benefits and risks based on current findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for bipolar disorder, which often involve medication like mood stabilizers and antipsychotics, MR-guided focused ultrasound capsulotomy offers a non-invasive, targeted approach. This treatment uses focused ultrasound waves to thermally ablate specific brain areas, potentially providing relief for those with treatment-resistant bipolar depression. Researchers are excited about this technique because it directly targets the anterior limb of the internal capsule, offering a novel mechanism of action that could reduce symptoms without the side effects associated with traditional medications.

What evidence suggests that MR-guided focused ultrasound is effective for treatment-resistant bipolar depression?

REVISED FAQ ANSWER:

Early research suggests that MR-guided focused ultrasound on both sides of the brain may help reduce symptoms in people with bipolar depression unresponsive to other treatments. This technique uses sound waves to target specific brain areas and has shown promise in easing depression symptoms in similar conditions. In this trial, all participants will undergo MR-guided focused ultrasound capsulotomy targeting the anterior limb of the internal capsule. One study found that this method significantly improved anxiety and depression symptoms. Another report noted a high rate of significant symptom reduction in patients with obsessive-compulsive symptoms using a similar approach. These initial results offer hope for its effectiveness in treating challenging cases of bipolar depression. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with bipolar depression who haven't improved after trying other treatments. Participants must be adults diagnosed with treatment-resistant bipolar depression, able to give informed consent, and meet specific health criteria not detailed here.

Inclusion Criteria

I am mentally capable and agree to participate in all study requirements.

I have been diagnosed with Bipolar Disorder, Type 1 or Type 2.

My depression score is 20 or higher and my episode has lasted 2 weeks or more.

Exclusion Criteria

I am currently taking medication that affects blood clotting.

Current or recent participation in another clinical trial

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months

Treatment

Participants undergo MR-guided focused ultrasound capsulotomy targeting the anterior limb of the internal capsule

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

7 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MR-guided Focused Ultrasound Bilateral Capsulotomy

Trial Overview The study tests the safety and initial effectiveness of a procedure called MR-guided focused ultrasound bilateral capsulotomy (ExAblate Neuro 4000) on patients with treatment-resistant bipolar depression.

How Is the Trial Designed?

Group I: MR-guided Focused Ultrasound Capsulotomy in Treatment-Resistant Bipolar Depression Experimental Treatment 1 Intervention

Participants in this arm will undergo MR-guided focused ultrasound (MRgFUS) capsulotomy targeting the anterior limb of the internal capsule. The procedure is intended to thermally ablate this brain region to assess safety and initial effectiveness in reducing symptoms of treatment-resistant bipolar depression (TRBD). All participants will receive the same intervention and will be followed for 24 months post-treatment to evaluate clinical outcomes, adverse events, and quality of life.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07108257

Magnetic Resonance-Guided Focused Ultrasound Bilateral ... The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients ...

2. trialx.com trialx.com/clinical-trials/listings/311899/magnetic-resonance-guided-focused-ultrasound-bilateral-capsulotomy-for-the-treatment-of-refractory-bipolar-depression/

Clinical Research Trial Listing ( Bipolar Depression The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients ...

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

A study of novel bilateral thermal capsulotomy with focused ... Bilateral thermal lesioning of the anterior limb of the internal capsule using MRgFUS may improve obsessive–compulsive, depressive and anxiety symptoms in ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.640832/full

Potential for use as a Novel Ablative Surgical Technique In our very recent study (77), we successfully performed bilateral thermal capsulotomy with MRgFUS in four patients with treatment-resistant ...

5. thejns.org thejns.org/focus/view/journals/neurosurg-focus/57/3/article-pE8.xml

A systematic review of focused ultrasound for psychiatric ... Bilateral anterior capsulotomy resulted in a full responder rate of 67% (≥ 35% reduction in the Yale-Brown Obsessive-Compulsive Scale score) and 33% (≥ 50% ...

6. withpower.com withpower.com/trial/phase-bipolar-disorder-5-2025-261aa

Focused Ultrasound for Bipolar Disorder The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients ...