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Behavioural Intervention

Cranial Electrotherapy Stimulation for Anxiety

N/A
Recruiting
Research Sponsored by David Moss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active Duty and DoD Beneficiaries aged 18 or older
Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 8 (week 10)

Summary

This trial aims to test the effectiveness of CES as a treatment for generalized anxiety in military personnel. The trial will compare CES with a placebo treatment.

Who is the study for?
This trial is for active duty military and DoD beneficiaries over 18 who can receive care at Nellis Air Force Base. Participants must show signs of anxiety with specific scores on the MINI and GAD-7 assessments.
What is being tested?
The study tests Alpha-Stim 100, a device providing Cranial Electrotherapy Stimulation (CES), against a sham device to see if it helps reduce anxiety symptoms in participants.
What are the potential side effects?
While not specified here, CES devices like Alpha-Stim may cause mild side effects such as headache, dizziness, or skin irritation at the electrode sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and either active duty or a DoD beneficiary.
Select...
I have been diagnosed with moderate to severe anxiety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 8 (week 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 8 (week 10) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Beck Anxiety Inventory (BAI)
Hamilton Anxiety Rating Scale (HAM-A)
Heart Rate Variability (HRV)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Active CESExperimental Treatment1 Intervention
Active CES treatment at home 40 minutes daily for 6 weeks
Group II: Group 2: Sham CESPlacebo Group1 Intervention
Sham CES treatment at home 40 minutes daily for 6 weeks

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Who is running the clinical trial?

David MossLead Sponsor
4 Previous Clinical Trials
622 Total Patients Enrolled
~38 spots leftby Jun 2025
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