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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 is to study the safety and feasibility of using a technology called Low Intensity Focused Ultrasound (LIFU) to treat patients with obsessive-compulsive disorder (OCD). The device is used to send high frequency sound waves to a particular region of the brain called the Ventral Striatum (VS). LIFU is a non-invasive form of stimulation, which can be used to stimulate deep regions of the brain. The trial will last two weeks with three weekly treatment sessions.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

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.

Find a Location

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
3,002 Previous Clinical Trials
1,794,259 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
~0 spots leftby Aug 2024