Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Margaret G Distler, MD,PhD (ucla)Taylor P Kuhn, PhD (ucla)

Description

Summary

There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.

Official Title

Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)

Details

Anxiety disorders have tremendous disease burden in the United States. Up to 1 in 3 Americans will be diagnosed with an anxiety disorder in their lifetimes. Anxiety treatment is typically consisting of psychotherapy (e.g. cognitive behavioral therapy) and medication management (e.g. benzodiazepines, selective serotonin reuptake inhibitors, etc). With major depressive disorder, rTMS is a suitable alternative treatment for refractory depression, rTMS is not approved for treatment of anxiety, nor can rTMS stimulate deep enough to reach those brain circuits involved in anxiety (e.g. the amygdala). Focused ultrasound is a new treatment modality being developed for several different neuropsychiatric conditions. In this study, the investigators propose to randomize 48 individuals to either active or sham treatment. Each participant will be evaluated to establish a baseline diagnose of generalized anxiety disorder, and then will be reassessed after each treatment session (of which there are four). One week and one month after the last treatment session, the investigators will conduct follow-up evaluations.

Keywords

Generalized Anxiety Disorder, focused ultrasound, Anxiety Disorders, Active LIFUP Treatment, Low Intensity Focused Ultrasound

Eligibility

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Medical University of South Carolina accepting new patients
    Charleston South Carolina 29425 United States
  • Massachusetts General Hospital accepting new patients
    Boston Massachusetts 02129 United States

Lead Scientists at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04557891
Study Type
Interventional
Participants
Expecting 48 study participants
Last Updated