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

Description

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.

Conditions

Generalized Anxiety Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Generalized Anxiety Disorder
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02129

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female
  • 2. Age 18-65
  • 3. Normal or corrected-to normal vision and hearing
  • 4. Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A\>17) 4a) The duration of the illness must exceed one year.
  • 5. Must be medically stable as determined by investigator
  • 6. Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
  • 7. History of rTMS is permitted, but not required.
  • 1. Diagnosis of primary DSM-5 anxiety disorder other than GAD 1a) Affective disorders such as unipolar or bipolar depression are permitted as long as GAD is primary
  • 2. Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
  • 3. Contraindication to enter the MRI environment
  • 4. Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
  • 5. Inability to adhere to treatment schedule
  • 6. Initiation of new anxiolytic treatment at the time of study randomization

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Margaret G Distler, MD,PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Taylor P Kuhn, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2025-12