What is the mechanism of action of this treatment?

Common treatments for Obsessive-Compulsive Disorder (OCD) include cognitive-behavioral therapy (CBT), selective serotonin reuptake inhibitors (SSRIs), and neuromodulation techniques like Deep Brain Stimulation (DBS) and Low Intensity Focused Ultrasound (LIFU). CBT works by exposing patients to anxiety-provoking stimuli and preventing their usual compulsive responses, thereby reducing the power of obsessions and compulsions. SSRIs increase serotonin levels in the brain, which helps regulate mood and anxiety. Neuromodulation techniques like DBS and LIFU target specific brain regions involved in OCD, such as the Ventral Striatum, to modulate neural activity and reduce symptoms. Understanding these mechanisms is crucial for OCD patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.

What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include cognitive-behavioral therapy (CBT), selective serotonin reuptake inhibitors (SSRIs), and non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS). Known side effects of SSRIs can include nausea, headache, sleep disturbances, and sexual dysfunction. For non-invasive brain stimulation techniques like TMS, side effects may include scalp discomfort, headache, and, in rare cases, seizures. While specific data on Low Intensity Focused Ultrasound (LIFU) is limited, it is generally considered safe with potential side effects being mild and transient, such as slight discomfort or headache.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for 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 are aimed at reducing the symptoms of OCD by altering serotonin levels in the brain. While non-invasive brain stimulation techniques like Low Intensity Focused Ultrasound (LIFU) are currently being studied for their potential benefits in treating OCD, they have not yet received FDA approval. Other non-invasive treatments, such as transcranial magnetic stimulation (TMS), have shown promise in clinical trials but are still under investigation for their efficacy and safety in OCD treatment.

What other types of research exist?

Promising, novel alternatives to Low Intensity Focused Ultrasound (LIFU) for treating Obsessive-Compulsive Disorder (OCD) include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in various studies for different psychiatric conditions, including OCD. 2) Transcranial Direct Current Stimulation (tDCS), which has been systematically reviewed and meta-analyzed for its potential benefits in bipolar depression and may have applications in OCD. 3) Vagus Nerve Stimulation (VNS), which has been studied for treatment-resistant depression and may offer benefits for OCD patients. These alternatives provide non-invasive or minimally invasive options for patients seeking novel treatments.

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Ultrasound Therapy

LIFU for OCD (LIFU Trial)

N/A

Recruiting

Led By Wayne Goodman, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial tests a new treatment called Low Intensity Focused Ultrasound (LIFU) for people with OCD who haven't responded to usual treatments. LIFU uses sound waves to stimulate a specific brain area, aiming to improve symptoms. The study will observe changes in brain activity and OCD symptoms over a short period of treatment.

Who is the study for?

This trial is for adults aged 21-55 with a main diagnosis of OCD lasting over 2 years. They must have tried at least two types of SSRIs or one SSRI and clomipramine without success, and if on medication, it should be stable for 2 months before the study. Women must use contraception, and participants can't have had more than four failed SSRI/clomipramine treatments.

What is being tested?

The trial tests Low Intensity Focused Ultrasound (LIFU) using BX Pulsar 1002 to stimulate the brain's Ventral Striatum region in patients with OCD. It's non-invasive and paired with MRI scans to observe changes in brain activity related to OCD symptoms during six sessions over two weeks.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing an MRI-compatible head device during treatment sessions, headache or dizziness post-treatment due to sound wave stimulation, or anxiety from being inside an MRI machine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acute changes in domains of mood, anxiety, alertness in response to VS LIFU after each sonication session as assessed by the Likert scale.

Magnetic Resonance Imaging

Primary study endpoint for OCD severity will be change in Y-BOCS score after 6 sonication sessions compared to baseline.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LIFU in OCD groupExperimental Treatment1 Intervention

Each subject will receive 3 LIFU sessions epr week for two weeks (6 total image-guided treatments). A total of 20 sonications will be administered to one side of the head, with a derated (based on FDA standard of 0.3 dB/cm-MHz) spatial-peak temporal-average intensity (i.e., Ispta) of approximately 720mW/cm2, each lasting 30 s, separated by 30 s pause intervals. Thus, total duration of sonication will be 10 minutes, the same as used in our study of VS LIFU in healthy subjects. Sonication will be administered within a 3T Siemens Prisma scanner. During sonication, we will use the 20-channel head coil as the 32-or 64-channel coil does not allow enough space to fit the transducer. In summary, the entire sequence of 20 sonications, each lasting 30s, separated by 30s pause intervals, will be administered over 20 minutes for a total duration of sonication equal to 10 minutes.

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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

Common treatments for Obsessive-Compulsive Disorder (OCD) include cognitive-behavioral therapy (CBT), selective serotonin reuptake inhibitors (SSRIs), and neuromodulation techniques like Deep Brain Stimulation (DBS) and Low Intensity Focused Ultrasound (LIFU). CBT works by exposing patients to anxiety-provoking stimuli and preventing their usual compulsive responses, thereby reducing the power of obsessions and compulsions. SSRIs increase serotonin levels in the brain, which helps regulate mood and anxiety. Neuromodulation techniques like DBS and LIFU target specific brain regions involved in OCD, such as the Ventral Striatum, to modulate neural activity and reduce symptoms. Understanding these mechanisms is crucial for OCD patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.

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Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,006 Previous Clinical Trials

6,003,288 Total Patients Enrolled

14 Trials studying Obsessive-Compulsive Disorder

742 Patients Enrolled for Obsessive-Compulsive Disorder

Massachusetts General HospitalOTHER

2,955 Previous Clinical Trials

13,212,658 Total Patients Enrolled

26 Trials studying Obsessive-Compulsive Disorder

1,612 Patients Enrolled for Obsessive-Compulsive Disorder

M.D. Anderson Cancer CenterOTHER

3,003 Previous Clinical Trials

1,794,369 Total Patients Enrolled

Media Library

Obsessive-Compulsive Disorder Research Study Groups: LIFU in OCD group

Obsessive-Compulsive Disorder Clinical Trial 2023: BX Pulsar 1002 Highlights & Side Effects. Trial Name: NCT05467085 — N/A

BX Pulsar 1002 (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467085 — N/A

~6 spots leftby Sep 2025

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