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NCT04557891 · ClinicalTrials.gov registry record · NA

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

A NA study of Generalized Anxiety Disorder, sponsored by University of California, Los Angeles.

Recruiting
Registry status
NA
Development phase
48
Enrollment target
3
Study locations

NCT04557891 is a NA study of Generalized Anxiety Disorder that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 48 participants, below the 214-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT04557891, a NA study of Generalized Anxiety Disorder, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
NA
Development phase
48 participants
Enrollment target
3
Study locations

Study 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.

Interventions

  • DEVICE Active LIFUP Treatment
  • DEVICE Sham LIFUP Treatment

Study Locations (3)

California

  • University of California, Los Angeles - Los Angeles

Massachusetts

  • Massachusetts General Hospital - Boston

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2021-07-26
Est. Completion 2027-12
Phase NA

What the Registry Record Tells You About NCT04557891

The ClinicalTrials.gov registry entry for NCT04557891 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 214-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (78% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions - of which Active LIFUP Treatment is the first listed.

NCT04557891 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Massachusetts, South Carolina.

Frequently Asked Questions

What is clinical trial NCT04557891 about?

NCT04557891 is a clinical study titled "Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)". 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 amygdal...

What is the current status of trial NCT04557891?

This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2021-07-26. Estimated completion is 2027-12.

What conditions does trial NCT04557891 study?

This clinical trial studies the following conditions: Generalized Anxiety Disorder.

What interventions are being tested in trial NCT04557891?

The interventions under investigation include: Active LIFUP Treatment (DEVICE), Sham LIFUP Treatment (DEVICE).

Who is sponsoring clinical trial NCT04557891?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04557891 being conducted?

This trial has 3 study locations across California, Massachusetts, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.