Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT07151248

Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome

Led by Emory University · Updated on 2026-04-22

130

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

C

Congressionally Directed Medical Research Programs

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 40 to 80 years old
  • Meet Gulf War Illness criteria based on CDC and Kansas standards
  • CDC criteria: symptoms in at least 2 categories (fatigue; mood and cognition; musculoskeletal) lasting 6 months or more
  • Kansas criteria: symptoms in at least 3 of 6 domains since 1990 without exclusionary diagnoses
  • Report consistent daily pain of 4 or higher on the Defense and Veterans Pain Rating Scale for more than 90 days before enrollment
  • Have intact skin free of infection at the electrode placement site (earlobe)
  • Willing and able to understand and participate in the consent process
  • Be right-handed for consistency in brain structure and function
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • History of drug abuse or severe uncontrolled psychiatric illness (schizophrenia or major depressive disorder with suicidal thoughts)
  • Skin conditions like psoriasis vulgaris that increase infection risk at electrode sites
  • Starting new medications or treatments for symptoms during the study
  • Severe anxiety, claustrophobia, or inability to lie still during MRI scans without sedation
  • Implanted electrical devices incompatible with MRI (e.g., vagal stimulator, pacemaker, spinal pain pump)
  • History of seizures or neurological conditions affecting brain structure
  • Allergy to metals used in CES electrodes
  • Diagnosed autoimmune diseases that explain pain symptoms better than Gulf War Illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory Clinic

Atlanta, Georgia, United States, 30307

Actively Recruiting

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Research Team

K

Katherine Egan, RN, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome | DecenTrialz