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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Male or female

• Age 18-65

• Normal or corrected-to normal vision and hearing

• Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A\>17) 4a) The duration of the illness must exceed one year.

• Must be medically stable as determined by investigator

• Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation

• History of rTMS is permitted, but not required.

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Margaret G Distler, MD,PhD
mdistler@mednet.ucla.edu
(310) 794-1553
Backup
Andrew Swenson, BS
aswenson@mednet.ucla.edu
(310) 206-5133
Time Frame
Start Date: 2021-07-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 48
Treatments
Experimental: Low Intensity Focused Ultrasound
Device: Low Intensity Focused Ultrasound Device~Low Intensity Focused Ultrasound Pulsation (LIFUP) of amygdala (a key area for anxiety) will be performed during two sessions. The proposed experiment will involve behavioral (e.g. HAM-A) and paramedical (i.e., MRI/fMRI) measurements just before and after each of the two LIFUP sessions (i.e., 5 non-consecutive minutes of stimulation in each session). The device does not produce a sound when operating and as such, the active group will well blinded.
Sham_comparator: Sham
Sham Treatment consists of placing the device but not turning it on. The device does not produce a sound when operating and as such, the sham group will well blinded.
Sponsors
Collaborators: Medical University of South Carolina, Massachusetts General Hospital
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov