RecruitingNot ApplicableNCT04557891

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

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


Sponsor

University of California, Los Angeles

Enrollment

48 participants

Start Date

Jul 26, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a brain stimulation technique using low-intensity focused ultrasound (like very gentle sound waves aimed at a specific brain region) to treat generalized anxiety disorder (GAD) in people whose anxiety has not improved with medications. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with moderate-to-severe generalized anxiety disorder (GAD) lasting more than one year - You have tried and not responded to at least 2 different SSRI medications and one additional treatment - You are medically stable **You may NOT be eligible if...** - You have another primary anxiety condition (other than GAD) - You are using non-prescribed psychoactive substances or drugs - You have a condition that prevents you from safely having an MRI (such as a pacemaker or metal implant) - You are pregnant or planning to become pregnant - You are starting a new anxiety medication at the time of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive LIFUP Treatment

8 LIFUP Treatments

DEVICESham LIFUP Treatment

8 sham LIFUP treatments


Locations(3)

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

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NCT04557891


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