Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07151248
Status
Recruiting
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Conditions

  • Gulf War Syndrome

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cranial electrical/electrotherapy stimulation (CES) — DEVICE
    Cranial electrical/electrotherapy stimulation (CES) is a non-pharmacological, portable, non-invasive intervention. Active research units will be locked at the specified amplitude and administer that amplitude of stimulation for 60 minutes therapy.
  • Sham Cranial electrical/electrotherapy stimulation (CES) — DEVICE
    Sham research units will be locked into active sham mode which provides stimulation designed to provide the sensation of stimulation for only 5 minutes while continuing to count down for the remaining 55 minutes.

Study Details

The main goal of the proposed study is to critically evaluate a nonpharmacological and readily available therapy, cranial electrical stimulation (CES) using Alpha-Stim™, and to discover the brain function mechanisms underlying Gulf War Illness-related Headache and Pain (GWI-HAP) and treatment response to CES. For this objective, the investigators will employ an adaptive trial design as well as a neuroimaging technique using MRI, which has become the pre-eminent technique for assessing the integrity of brain function, connectivity, and organization in healthy brain and pathology.

Key Dates

Start date
Sep 26, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: True CES therapy
    The participant will be trained in device usage and instructed to use the device each evening around the same time for 60 minutes (timer will be pre-set). The intervention (true CES) will occur over the course of 6 weeks.
  • Sham Comparator: Sham CES therapy
    The participant will be trained in device usage and instructed to use the device each evening around the same time for 60 minutes (timer will be pre-set). The intervention (sham CES) will occur over the course of 6 weeks.
  • Experimental: True CES therapy for non-responders
    For the non-responders (\<2 point decrease on DVPRS), the blind will be broken, and those non-responder participants who were initially assigned to sham placebo CES during the first 6 weeks of the intervention, now will be offered the opportunity to utilize the true CES device in a modified sequential parallel comparison design for an additional 6 weeks.

Primary Outcome Measure

Change in Defense and Veterans Pain Rating Scale (DVPRS) from baseline [ Time Frame: Baseline, 6 and 12 weeks post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory ClinicAtlantaGeorgia30307
Katherine Egan, RN, CCRC
[email protected]
404-727-8463

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By research site
Emory Clinic· Atlanta, GA

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