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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04557891
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active LIFUP Treatment — DEVICE
    8 LIFUP Treatments
  • Sham LIFUP Treatment — DEVICE
    8 sham LIFUP treatments

Study Details

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.

Key Dates

Start date
Jul 26, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Margaret G Distler, MD, PhD
[email protected]
310-794-1553
Andrew Bishay
[email protected]
Margaret G Distler, MD,PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02129
Darin Dougherty
[email protected]
617-724-9247
Darin D Dougherty, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Elisabeth Collins
[email protected]
843-638-7517
Mark S George, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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