CES for the Treatment of GAD in Young Adults

Status Recruiting

Clinical Trial Summary

The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.

Clinical Trial Description

This study examines (1) the efficacy of CES with the Alpha-Stim AID ® for the treatment of GAD in young adults (18-21 years of age) in a double-blind, sham-controlled parallel group single-site clinical trial of 130 participants. Participants will be randomized into receiving either active CES (at least 200uA, up to 500uA at 0.5Hz, 60 minutes daily for six weeks) or sham CES with the Alpha-Stim AID ® device at-home. Clinical assessments of anxiety symptoms are performed at Screening (for eligibility), Baseline, Follow-Up 1 (at completion of intervention, 6 weeks after initial stimulation), and Follow-Up 2 (12 weeks after initial stimulation). Additional assessments of depression symptoms and quality of life are included. Resting-state EEG will be collected at baseline and Follow-Up 1 (in up to 60 participants) for exploratory investigation of mechanism of action. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06124014
Study type	Interventional
Source	Electromedical Products International, Inc.
Contact	Tobias Schwippel, MD
Phone	919-966-9929
Email	tobias_schwippel@unc.edu
Status	Recruiting
Phase	N/A
Start date	January 26, 2024
Completion date	March 2026

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