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.
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.
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)
Parallel
Active LIFUP Treatment
Device8 LIFUP Treatments
Sham LIFUP Treatment
Device8 sham LIFUP treatments
Hamilton Anxiety Rating Scale (HAM-A)
HAM-A is a rating scale for measuring the severity of anxiety symptoms.
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Massachusetts General Hospital
Collaborator
Medical University of South Carolina
Collaborator
