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Imaging-Guided Low Intensity Focused Ultrasound (LIFU)

NCT05467085 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-18

No results posted yet for this study

Summary

This research study is to investigate the safety, feasibility, and possible therapeutic benefits of a technology called Low Intensity Focused Ultrasound (LIFU) in patients with obsessive- compulsive disorder (OCD). The device used in this study transmits 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. In this study, the investigators will administer LIFU to activate the VS area of the brain while also observing this brain stimulation with an MRI machine. Other aims of this study include learning more about the patterns of brain activity associated with OCD and seeing if brain activity changes as symptoms of OCD change over time during the two weeks of LIFU stimulation. Participants in this study will be asked to perform computer administered behavioral tasks -- similar to simple computer games -- to examine whether certain features of OCD (e.g., avoidance of feared triggers) change over the course of LIFU stimulation.

The treatment phase of this research study is expected to last two weeks with three weekly (total of 6) treatment sessions all carried at the MRI brain imaging center at Baylor College of Medicine. There will be at least one additional screening visit before treatment starts and a series of follow up visits over a six-month period.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DEVICE

BX Pulsar 1002

Imaging-Guided Low Intensity Focused Ultrasound Pulsation (LIFU) device

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Wayne Goodman, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2026-08-01
Completion
2026-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05467085 on ClinicalTrials.gov