NCT07151248 Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome
| NCT ID | NCT07151248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Gulf War Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-09-26 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Anna Woodbury, MD, MSc
PRINCIPAL INVESTIGATOR
Emory University 404-727-8463
Frequently Asked Questions
Who can join the NCT07151248 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Gulf War Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07151248 currently recruiting?
Yes, NCT07151248 is actively recruiting participants. Contact the research team at kfegan@emory.edu for enrollment information.
Where is the NCT07151248 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07151248 clinical trial?
NCT07151248 is sponsored by Emory University. The principal investigator is Anna Woodbury, MD, MSc at Emory University 404-727-8463. The trial plans to enroll 130 participants.