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Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome

NCT07151248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Gulf War Syndrome

Interventions

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.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Emory University

    lead OTHER

Principal Investigators

  • Anna Woodbury, MD, MSc · Emory University 404-727-8463

  • Lisa C Krishnamurthy, PhD · Emory University 404-712-5332

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2029-09-30
Completion
2029-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151248 on ClinicalTrials.gov