Recruiting

LIFUP

Sponsor:

UCLA

Code:

NCT04557891

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active LIFUP Treatment

Sham LIFUP Treatment

Study Details

Brief 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.

Conditions

Generalized Anxiety Disorder

Study ID

NCT04557891

Start date

Jul 26, 2021

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Active LIFUP Treatment

8 LIFUP Treatments

Sham LIFUP Treatment

8 sham LIFUP treatments

Primary outcome measure

  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 1 week after the fourth LIFUP treatment ]

Central Contacts and Locations

Central contacts

Margaret G Distler, MD,PhD

(310) 794-1553mdistler@mednet.ucla.edu

Andrew Bishay, BS

4243719869abishay@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Margaret G Distler, MD, PhD

310-794-1553mdistler@mednet.ucla.edu

Andrew Bishay

abishay@mednet.ucla.edu

Principal Investigator:

Margaret G Distler, MD,PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Darin Dougherty

617-724-9247ddougherty@mgb.org

Principal Investigator:

Darin D Dougherty, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Elisabeth Collins

843-638-7517collieli@musc.edu

Principal Investigator:

Mark S George, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • focused ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-10.