NCT07151248

Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome

ELECTRIG: Evaluating Effects of Cranial Electrical Stimulation Therapy With Responsive Imaging in Gulf War Illness Pain and Comorbid Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Gulf War Veterans are disproportionately plagued by fibromyalgia-like symptoms including headaches, joint, and muscle pain, known as gulf war illness pain or GWI-HAP. Treatment options are limited, and the neurobiology of these symptoms is poorly understood. In this population, the investigators plan to test a portable, non-pharmacological, non-invasive therapy (Alpha-Stim™) that is FDA-cleared for anxiety, insomnia, and pain, and readily available for widespread implementation in the United States. This cranial electrical stimulation (CES) device has shown promising, though limited results for anxiety, insomnia, and pain. They also plan to employ magnetic resonance spectroscopy (MRS) to evaluate neuroinflammation. Subjects will be male and females, age 40-80 years old, with a diagnosis of Gulf war illness. Subjects will be recruited by referral and posted flyers on Emory campus, ResearchMatch, the Gulf War Registry, and the Wounded Warriors' Program. The research team will not approach vulnerable populations including minors, prisoners, pregnant persons, neonates or human fetuses, wards of the state, or cognitively impaired persons. Recruitment, screening and enrollment will occur at the Emory clinics (EUHM and EUH) and the Human Subjects Research Building II. This randomized, double-blind, sham-controlled study will compare the efficacy of "active" or true CES therapy to "sham" CES therapy. Participants will be randomized in a 1:1 ratio to true or sham CES (n=104 total; 52 true, 52 sham). Up to 130 subjects will be enrolled to achieve 104 treated subjects. Baseline assessments including quality of life questionnaires and pain assessments, in addition to MRI will be obtained prior to initiation of the intervention. 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). They will also be provided detailed instructions. The intervention (both sham and true CES) will occur over the course of 6 weeks, and participants will be assessed again post-treatment. To assess our neuroimaging outcomes, MRI will also be obtained at 6 weeks post-treatment, to assess for changes in connectivity and neuroinflammation. The total time commitment for most subjects will be 7 weeks. Participants who are initially randomized to sham and are determined to be non-responders (\<2 point decrease on DVPRS) will be offered the opportunity to utilize the true CES therapy with additional reimbursement and follow-up periods. They will use the device for an additional 6 weeks and return for post-treatment follow up at that time (12 weeks after initial therapy) that will include additional MRI and the original baseline and 6-week assessments. The total time commitment for these subjects will be 13 weeks. A verbal prescreening consent will be used to confirm eligibility. Informed consent will be conducted in person with the participant and written, or over the telephone or zoom with consent signed using Hipaa Part 11 compliant DocuSign. Participants may also consent to be contacted for future research.

Conditions

• Gulf War Syndrome

Interventions

Type	Name	Description
DEVICE	Cranial electrical/electrotherapy stimulation (CES)	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.
DEVICE	Sham Cranial electrical/electrotherapy stimulation (CES)	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.

Timeline

• Start date: 2025-09-26
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2025-09-03
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study