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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557891
• Other study ID #: CTP-LIFUP-GAD-V1.0
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: University of California, Los Angeles
• Contact: Margaret G Distler, MD,PhD
• Phone: (310) 794-1553
• Email: mdistler[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Anxiety disorders have tremendous disease burden in the United States. Up to 1 in 3 Americans will be diagnosed with an anxiety disorder in their lifetimes. Anxiety treatment is typically consisting of psychotherapy (e.g. cognitive behavioral therapy) and medication management (e.g. benzodiazepines, selective serotonin reuptake inhibitors, etc). With major depressive disorder, rTMS is a suitable alternative treatment for refractory depression, rTMS is not approved for treatment of anxiety, nor can rTMS stimulate deep enough to reach those brain circuits involved in anxiety (e.g. the amygdala). Focused ultrasound is a new treatment modality being developed for several different neuropsychiatric conditions. In this study, the investigators propose to randomize 48 individuals to either active or sham treatment. Each participant will be evaluated to establish a baseline diagnose of generalized anxiety disorder, and then will be reassessed after each treatment session (of which there are four). One week and one month after the last treatment session, the investigators will conduct follow-up evaluations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female

2. Age 18-65

3. Normal or corrected-to normal vision and hearing

4. Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A>17) 4a) The duration of the illness must exceed one year.

5. Must be medically stable as determined by investigator

6. Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation

7. History of rTMS is permitted, but not required.

Exclusion Criteria:

1. 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

2. Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)

3. Contraindication to enter the MRI environment

4. Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)

5. Inability to adhere to treatment schedule

6. Initiation of new anxiolytic treatment at the time of study randomization

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• Active LIFUP Treatment
8 LIFUP Treatments
• Sham LIFUP Treatment
8 sham LIFUP treatments

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Massachusetts General Hospital, Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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