What side effects are associated with this type of intervention?

Common treatments for OCD include deep brain stimulation (DBS), transcranial magnetic stimulation (TMS), pharmacotherapy, and cognitive-behavioral therapy (CBT). DBS can lead to surgical complications, device-related issues, and undesired effects from stimulation. TMS is generally well-tolerated but can cause headaches, scalp discomfort, and, rarely, seizures. Pharmacotherapy, particularly with SSRIs, may result in nausea, insomnia, and sexual dysfunction. CBT, specifically exposure and response prevention, is effective but can be emotionally challenging for patients.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, and sertraline, as well as the tricyclic antidepressant clomipramine. These medications help reduce OCD symptoms by increasing serotonin levels in the brain. While the context does not provide specific information on treatments similar to ultrasound modulation of neural activity, it is important to note that such neuromodulation techniques are still largely experimental and not yet FDA-approved for OCD.

What other types of research exist?

Promising novel alternatives to ultrasound for treating OCD in 2024 include: 1) Intensive Orbitofrontal Continuous Theta Burst Stimulation (iOFcTBS), which targets the hyper-connectivity between the orbito-frontal cortex and the striatum, showing efficacy in a randomized placebo-controlled study. 2) Transcranial Magnetic Stimulation (TMS), which non-invasively modulates specific brain regions implicated in OCD. 3) Pharmacological augmentation with memantine or riluzole, which have shown benefits in treatment-resistant OCD in various studies.

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Focused Ultrasound

Focused Ultrasound for Obsessive-Compulsive Disorder

N/A

Waitlist Available

Led By Sheldon Jordan, MD

Research Sponsored by Neurological Associates of West Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failure to remit with 3 SSRIs, antidepressants and/or anxiolytics

At least 18 years of age

Must not have

Any active cancer or chemotherapy

Any other neoplastic illness or illness characterized by neovascularity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks from baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects of focused ultrasound may include discomfort at the treatment site, headache or dizziness during or after treatment. Long-term side effects are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I have been diagnosed with Obsessive Compulsive Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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

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I am unable to understand and give consent for treatment.

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I am not proficient in English.

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I can't stay still enough to fall asleep in a calm environment.

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I have severe kidney, lung, heart, or liver disease.

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I have macular degeneration.

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I have a scalp rash or open wounds on my scalp.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anxiety

Beck Depression Inventory (BDI-II)

Global Rating of Change (GRC)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focused Ultrasound

2012

Completed Phase 2

~50

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs), cognitive-behavioral therapy (CBT) with exposure and response prevention (ERP), and neuromodulation techniques like deep brain stimulation (DBS) and transcranial ultrasound. SSRIs work by increasing serotonin levels in the brain, which helps reduce OCD symptoms. CBT, particularly ERP, helps patients confront and manage their obsessions and compulsions through structured exposure to anxiety-provoking stimuli. Neuromodulation techniques like DBS and ultrasound aim to modulate neural activity in specific brain regions implicated in OCD, such as the cortico-striato-thalamo-cortical circuit. These treatments are crucial for OCD patients as they target the underlying neurobiological mechanisms, offering potential relief from symptoms that are often resistant to conventional therapies.

The Emergence of a Stereotypic Movement During Intensive Short-Term Dynamic Psychotherapy in a Patient with Obsessive Compulsive Disorder: A Case Report.Beyond refractory obsessions and anxiety states: toward remission.