Focused Ultrasound for Obsessive-Compulsive Disorder

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Cancer, Neoplastic illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores focused ultrasound as a new treatment for Obsessive-Compulsive Disorder (OCD). The goal is to determine if this method is safe and effective for individuals who haven't responded to at least three standard medications, such as SSRIs (a common type of antidepressant). Participants will undergo a brief ultrasound session targeting a specific brain area associated with OCD. This trial suits those with OCD who find their current treatments ineffective and can remain still during the procedure. As an unphased trial, it provides a unique opportunity to investigate innovative treatment options for OCD.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for those who have not improved with certain medications, you might be able to continue them. It's best to discuss this with the trial coordinators.

What prior data suggests that focused ultrasound is safe for treating Obsessive-Compulsive Disorder?

Research has shown that focused ultrasound is generally safe for treating conditions like Obsessive-Compulsive Disorder (OCD). One study found that using focused ultrasound on the brain is safe and effective, particularly for individuals with severe OCD symptoms. Another source highlights that this treatment is noninvasive, meaning it doesn't involve surgery, which can lower risks.

However, some questions about its safety remain, so more research is needed. This trial is in a phase called "Not Applicable," indicating that researchers are still assessing its effectiveness and safety. Focused ultrasound is under careful study, with participant safety as a top priority. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focused ultrasound is unique because it offers a non-invasive approach to treating Obsessive-Compulsive Disorder (OCD) by targeting specific brain regions with precision, without needing surgery or medications. Unlike traditional treatments like cognitive-behavioral therapy and medications such as SSRIs, which can take weeks or months to show significant effects, focused ultrasound could potentially provide faster symptom relief. Researchers are excited about its potential to precisely target the brain's caudate region, using advanced imaging techniques, which might lead to more effective and personalized treatment outcomes for patients with OCD.

What evidence suggests that focused ultrasound is effective for obsessive-compulsive disorder?

Research has shown that focused ultrasound, the treatment under study in this trial, can help treat obsessive-compulsive disorder (OCD). Studies have found that this treatment often provides symptom relief, especially for people with OCD. Focused ultrasound targets specific brain areas involved in OCD, such as the ventral capsule and ventral striatum. Some patients who haven't improved with other treatments have benefited from this method. Overall, this non-invasive approach has shown promise for those with severe, hard-to-treat OCD. ^{1 6 7 8 9}

Who Is on the Research Team?

Sheldon Jordan, MD

Principal Investigator

Neurological Associates of West LA

Are You a Good Fit for This Trial?

This trial is for adults with Obsessive-Compulsive Disorder who haven't improved after trying at least three different SSRIs, antidepressants, or anxiolytics. Participants must speak English, follow the study rules, and have a moderate to severe OCD diagnosis as indicated by scoring over 15 on the Y-BOCS.

Inclusion Criteria

I have tried 3 different SSRIs without improvement in my condition.

Score greater than 15 on the Yale-Brown Obsessive Compulsive Scale (Y- BOCS)

English Proficiency

Exclusion Criteria

I am currently receiving treatment for cancer.

I have a condition that involves abnormal growth of blood vessels.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 consecutive weekly sessions of transcranial low-intensity focused ultrasound (LIFUP) targeting the caudate of the basal ganglia

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Focused Ultrasound

Trial Overview The trial is testing focused ultrasound treatment's safety and effectiveness in treating OCD. It aims to see if this non-invasive method can help where traditional medications have failed.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the caudate. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.

Focused Ultrasound is already approved in United States, European Union for the following indications:

Approved in United States as Gemzar for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer

Approved in European Union as Gemzar for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Citations

1. 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 ... A clinical trial tested the safety and efficacy of using focused ultrasound to perform a capsulotomy in participants with obsessive-compulsive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06722339

Targeted Circuit-Based Transcranial Focused Ultrasound ... We will assess safety and efficiency of TUS to different parts of the brain in alleviating OCD symptoms. Official Title. Targeted Circuit-Based Transcranial ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39187171/

Long-Term Safety and Efficacy of Focused Ultrasound ... Conclusions: MRgFUS capsulotomy is safe in patients with OCD and MDD and particularly effective in the former population. Keywords: Capsulotomy; ...

4. mghpsychnews.org mghpsychnews.org/transcranial-focused-ultrasound/

Transcranial Focused Ultrasound: A New Frontier for Non- ... Reducing anxiety by targeting the amygdala; Treating obsessive-compulsive disorder (OCD) by targeting the ventral capsule/ventral striatum (VC/ ...

5. iocdf.org iocdf.org/recipients/clinical-trial-of-image-guided-low-intensity-focused-ultrasound-pulsation-lifup-for-the-treatment-of-obsessive-compulsive-disorder-ocd/

Clinical trial of image-guided low-intensity focused ... About one in three people with OCD do not get better after trying first-line treatments. For patients with severe, treatment-resistant OCD, Deep Brain ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322324015488

Long-Term Safety and Efficacy of Focused Ultrasound ... MRgFUS capsulotomy is safe in patients with OCD and MDD and particularly effective in the former population.

7. fusfoundation.org fusfoundation.org/diseases-and-conditions/obsessive-compulsive-disorder-ocd/

Obsessive-Compulsive Disorder (OCD) Focused ultrasound is a noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12148002/

Magnetic Resonance-Guided Focused Ultrasound ... MRgFUS neurosurgery may be an effective and generally safe treatment option for severe, treatment-refractory OCD, but the evidence is very uncertain.

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04775875

NCT04775875 | The Use of Transcranial Ultrasound ... The primary objective of this study is to determine the safety and efficacy of ultrasound as a treatment for Obsessive Compulsive disorder. Detailed Description.