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

Recruiting · NCT04557891 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

Active LIFUP TreatmentSham LIFUP Treatment

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.

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

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

Where it is running

3 locations listed across 3 US states.

University of California, Los Angeles - Los Angeles, California, United States
Massachusetts General Hospital - Boston, Massachusetts, United States
Medical University of South Carolina - Charleston, South Carolina, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →