Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome (NCT07151248) | Clinical Trial Compass
RecruitingNot Applicable
Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome
United States130 participantsStarted 2025-09-26
Plain-language summary
The main goal of the proposed study is to critically evaluate a nonpharmacological and readily available therapy, cranial electrical stimulation (CES) using Alpha-Stimâ„¢, 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects must be male and female age 40-80 years old
✓. Meet criteria for GWVI based on the CDC and Kansas Criteria for GWVI.
Exclusion criteria
✕. Subjects must self-report consistent, daily pain (greater than or equal to 4 on the DVPRS) \>90 days (prior to enrollment)
✕. Subjects must have intact skin free of infection at the site of electrode placement (earlobe).
✕. Subjects must be willing to participate and understand the consent.
✕. Subjects must be right-handed to provide consistency in brain structure and function.
✕. Subjects must not be currently pregnant since effects of fMRI and electrical current on the developing fetus are not well-known.
✕. Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
✕. Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
What they're measuring
1
Change in Defense and Veterans Pain Rating Scale (DVPRS) from baseline
Timeframe: Baseline, 6 and 12 weeks post-intervention
2
Change in Brief Pain Inventory (BPI) severity subscale from baseline
Timeframe: Baseline, 6 and 12 weeks post-intervention
3
Change in Brief Pain Inventory (BPI) pain interference subscale from baseline
Timeframe: Baseline, 6 and 12 weeks post-intervention