Focused Ultrasound for Obsessive-Compulsive Disorder

Recruiting 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

30 Participants Needed

Trial Summary

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

Research shows that magnetic resonance-guided focused ultrasound (MRgFUS) is a promising, minimally invasive treatment for obsessive-compulsive disorder (OCD), with studies indicating successful long-term relief when targeting specific brain areas. This technique has been associated with symptom improvement in patients who have not responded to other treatments. ^{1 2 3 4 5}

Is focused ultrasound safe for treating obsessive-compulsive disorder?

Focused ultrasound has been studied for treating obsessive-compulsive disorder, and in one study, patients showed no side effects related to the procedure over a 6-month period. This suggests it may be a safe option, but larger studies are needed to confirm its long-term safety. ^{1 2 4 5 6}

How is focused ultrasound treatment different for OCD?

Focused ultrasound is a unique treatment for OCD because it uses sound waves to create precise, incisionless brain lesions, unlike traditional surgical methods that require cutting into the brain. This approach is guided by MRI, allowing for targeted treatment of specific brain areas involved in OCD, and is particularly used for patients who have not responded to other treatments. ^{3 4 5 7 8}

What is the purpose of this trial?

This trial is testing the safety and effectiveness of using sound waves directed at the brain to treat patients with OCD who may not respond to usual treatments. The sound waves target a specific brain area to change its activity and reduce symptoms.

Research Team

Sheldon Jordan, MD

Principal Investigator

Neurological Associates of West LA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

The Potential Usefulness of Magnetic Resonance Guided Focused Ultrasound for Obsessive Compulsive Disorders. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Potential optimization of focused ultrasound capsulotomy for obsessive compulsive disorder. [2022]

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

Different magnetic resonance imaging patterns after transcranial magnetic resonance-guided focused ultrasound of the ventral intermediate nucleus of the thalamus and anterior limb of the internal capsule in patients with essential tremor or obsessive-compulsive disorder. [2015]

4. 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]

5. 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]

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]

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

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

8. 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]