An interventional study of At-Home Stimulation in Generalized Anxiety Disorder, sponsored by Electromedical Products International, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Electromedical Products International, Inc. · Not applicable, Interventional, and Treatment
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.
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.
131 studies on the registry are indexed under Generalized Anxiety Disorder; 83 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 105 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Electromedical Products International, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Time-frames are determined relative to the screening visit.
Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes.
Device: At-Home Stimulation
The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage.
Device: At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.
Hamilton Anxiety Rating Scale (HAM-A) change
Change in HAM-A between six-week follow-up (FU1) and baseline (D1); minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.
Time frame: 42 days
Hamilton Anxiety Rating Scale (HAM-A) change
Change in HAM-A between twelve-week follow-up (FU2) and D1; minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.
Time frame: 84 days
Beck Anxiety Inventory (BAI) Change
Change in BAI between FU1 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome.
Time frame: 42 days
Beck Anxiety Inventory (BAI) Change
Change in BAI between FU2 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome.
Time frame: 84 days
Generalized-Anxiety Disorder 7-item (GAD-7) Change
Change in GAD-7 between FU1 and D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome.
Time frame: 42 days
Generalized-Anxiety Disorder 7-item (GAD-7) Change
Change in GAD-7 between FU2 and baseline D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome.
Time frame: 84 days
Response/Remission of anxiety
Response/remission rates based on HAM-A scores from FU1 versus baseline D1
Time frame: 42 days
Response/Remission of anxiety
Response/remission rates based on HAM-A scores from FU2 versus baseline D1
Time frame: 84 days
Change in Clinical Global Impression Scale (CGI)
Change in CGI from FU1 to D1; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.
Time frame: 42 days
Change in Clinical Global Impression Scale (CGI)
Change in CGI from FU2 to baseline D1; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.
Time frame: 84 days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Change in Q-LES-Q-SF from FU1 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Time frame: 42 days
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Change in Q-LES-Q-SF from FU2 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Time frame: 84 days
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Electromedical Products International, Inc.