Actively Recruiting
Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
Led by University of California, Los Angeles · Updated on 2026-02-10
48
Participants Needed
3
Research Sites
331 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18-65
- Normal or corrected-to-normal vision and hearing
- Primary diagnosis of moderate to severe generalized anxiety disorder per DSM-5 with a Hamilton Anxiety Rating Scale (HAM-A) score greater than 17
- Anxiety disorder lasting longer than one year
- Medically stable as determined by the investigator
- Previous failure of treatment with at least two SSRIs and one augmentation therapy
- History of rTMS treatment allowed but not required
You will not qualify if you...
- Diagnosis of a primary anxiety disorder other than generalized anxiety disorder
- Current use of non-prescribed psychoactive medications or drugs (except those for GAD treatment)
- Contraindications for MRI environment
- Pregnancy, suspected pregnancy, or plans to become pregnant soon
- Inability to follow the treatment schedule
- Starting a new anxiolytic treatment at the time of study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
M
Margaret G Distler, MD,PhD
CONTACT
A
Andrew Bishay, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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