The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

Last updated: September 26, 2022
Sponsor: Neurological Associates of West Los Angeles
Overall Status: Active - Enrolling

Phase

N/A

Condition

Obsessive-compulsive Disorder

Kleptomania

Panic Disorders

Treatment

N/A

Clinical Study ID

NCT04775875
fUS-OCD
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to determine the safety and efficacy of ultrasound as a treatment for Obsessive Compulsive disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Obsessive Compulsive Disorder
  • Score greater than 15 on the Yale-Brown Obsessive Compulsive Scale (Y- BOCS)
  • Failure to remit with 3 SSRIs, antidepressants and/or anxiolytics
  • Must be willing to comply with the study protocol
  • English Proficiency
  • At least 18 years of age

Exclusion

Exclusion Criteria:

  • Subjects not English proficient
  • Subjects unable to give informed con-sent
  • Subjects who would not be able to lay down without excessive movement in a calmenvironment sufficiently long enough to be able to achieve sleep
  • Pregnancy, women who may become pregnant or are breastfeeding
  • Advanced terminal illness
  • Any active cancer or chemotherapy
  • Any other neoplastic illness or illness characterized by neovascularity
  • Macular degeneration
  • Subjects with scalp rash or open wounds on the scalp (for example from treatment ofsquamous cell cancer)
  • Advanced kidney, pulmonary, cardiac or liver failure

Study Design

Total Participants: 30
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2025

Study Description

The present study is being undertaken as an open-label study to evaluate the safety and feasibility of focused ultrasound as an intervention for patients with obsessive compulsive disorder (OCD). Participants in this study will undergo 8 consecutive weekly sessions of transcranial low-intensity focused ultrasound (LIFUP) targeting the caudate of the basal ganglia. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound for this neurological application. Treatment response will be measured using the Beck Depression & Anxiety Inventories, the Yale-Brown Obsessive-Compulsive Scale, and the Global Rating of Change Scale.

Connect with a study center

  • Neurological Associates of West LA

    Santa Monica, California 90403
    United States

    Site Not Available

  • Neurological Associates of West Los Angeles

    Santa Monica, California 90403
    United States

    Site Not Available

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