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-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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing Cranial Electrotherapy Stimulation, which is a non-drug approach using mild electrical stimulation — given that this is listed as Phase NA, meaning it may not follow the traditional drug trial phases, what is already known about the safety and effectiveness of this device for Gulf War Syndrome symptoms like my pain?
2The trial is measuring pain using tools like the Defense and Veterans Pain Rating Scale and the Brief Pain Inventory — do my current pain levels and symptoms match what they're looking for, and would my doctor say my pain profile fits what this study is designed to address?
3Since this trial involves brain imaging alongside the stimulation treatment, what does that actually mean for me in terms of how many visits, how long each session might take, and whether the logistics would be manageable with my current health situation?
4Are there established standard-of-care treatments for Gulf War Syndrome pain that I should consider trying first, or alongside this trial, before committing to a research study where outcomes are still being measured?
5Given that the trial is actively recruiting right now, what would my doctor need to know about my full medical history — including any other conditions or medications — before deciding whether discussing enrollment with the study team even makes sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Subjects must not introduce new medications or treatments for symptoms during the study to prevent confounding results.