Cranial electrical stimulation with brain imaging for Gulf War illness headaches and pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, sham-controlled adaptive trial will randomize 104 Gulf War veterans to active or sham cranial electrical stimulation (CES) to test symptom change. Participants will undergo brain imaging including MRI and magnetic resonance spectroscopy (MRS) to probe brain connectivity and possible neuroinflammation linked to headache and pain. The intervention uses an FDA‑cleared portable CES device (Alpha‑Stim) delivered repeatedly over the treatment period. Recruitment and clinical visits, including imaging, occur at Emory University clinics in Atlanta for adults aged 40–80 who meet CDC and Kansas criteria for Gulf War Illness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must be male and female age 40-80 years old
2. Meet criteria for GWVI based on the CDC and Kansas Criteria for GWVI.

   * CDC: 1 or more from at least 2 of the following categories for ≥ 6 months): 1) fatigue 2) mood and cognition (symptoms of feeling depressed, difficulty in remembering or concentrating, feeling moody, feeling anxious, trouble in finding words, or difficulty in sleeping) 3) musculoskeletal (symptoms of joint pain, joint stiffness, or muscle pain
   * Kansas: 3 of 6 domains: 1) fatigue and sleep problems 2) pain symptoms 3) neurologic, cognitive, or mood symptoms 4) gastrointestinal symptoms 5) respiratory symptoms 6) skin symptoms chronic since 1990. Symptom reporting must be in the absence of diagnosed exclusionary conditions; only respondents who have at least 1 moderately severe symptom or 2 or more symptoms within a group were considered to have a high level of symptoms in the group.
3. Subjects must self-report consistent, daily pain (greater than or equal to 4 on the DVPRS) \>90 days (prior to enrollment)
4. Subjects must have intact skin free of infection at the site of electrode placement (earlobe).
5. Subjects must be willing to participate and understand the consent.
6. Subjects must be right-handed to provide consistency in brain structure and function.

Exclusion Criteria:

1. Subjects must not be currently pregnant since effects of fMRI and electrical current on the developing fetus are not well-known.
2. Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
3. Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
4. Subjects must not introduce new medications or treatments for symptoms during the study to prevent confounding results.
5. Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
6. Subjects must not have an implanted electrical device such as a surgically placed vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
7. Subjects must not have a history of seizures or neurologic conditions that may alter the structure of the brain.
8. Subjects must not be allergic to the metals used in electrodes for CES stimulation.
9. Subjects must not have a diagnosed autoimmune disease that better explains pain symptoms.

Where it's running

• Emory Clinic
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Anna Woodbury, MD, MSc — Emory University 404-727-8463
• Study coordinator: Katherine Egan, RN, CCRC
• Email: kfegan@emory.edu
• Phone: 404-727-8463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.