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

NCT04557891 | Recruiting DMC FDA Device

• 1 other identifier: CTP-LIFUP-GAD-V1.0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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

Keywords

focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  HAM-A is a rating scale for measuring the severity of anxiety symptoms.

  1 week after the fourth LIFUP treatment

Study Arms (2)

Low Intensity Focused Ultrasound

EXPERIMENTAL

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.

Device: Active LIFUP Treatment

Sham

SHAM COMPARATOR

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.

Device: Sham LIFUP Treatment

Interventions

Active LIFUP Treatment DEVICE

8 LIFUP Treatments

Also known as: BX Pulsar 1002

Low Intensity Focused Ultrasound

Sham LIFUP Treatment DEVICE

8 sham LIFUP treatments

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
• Contraindication to enter the MRI environment
• Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
• Inability to adhere to treatment schedule
• Initiation of new anxiolytic treatment at the time of study randomization

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Massachusetts General Hospital: collaborator
• Medical University of South Carolina: collaborator

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Margaret G Distler, MD,PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret G Distler, MD,PhD

CONTACT

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

Andrew Bishay, BS

CONTACT

4243719869; abishay@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Assistant Clinical Professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: July 26, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)