Actively Recruiting
Evaluating Effects of Cranial Electrical Stimulation Therapy With Responsive Imaging in Gulf War Illness Pain and Comorbid Symptoms
Led by Emory University · Updated on 2026-04-22
130
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating cranial electrical stimulation (CES) therapy using the Alpha-Stim™ device to understand how it affects brain function and pain symptoms related to Gulf War Illness with headache and pain (GWI-HAP). This study aims to explore the brain mechanisms involved in this condition and how CES treatment might impact these processes using advanced MRI neuroimaging techniques. The study focuses on Gulf War Veterans aged 40 to 80 years who experience fibromyalgia-like symptoms including headaches, joint, and muscle pain. The study is a randomized, double-blind, sham-controlled trial comparing active CES therapy to a sham or placebo version of the CES device. Participants will be trained to use the device daily at home for 60 minutes each evening over a 6-week period. Those initially receiving sham treatment who do not respond may be offered active CES therapy for an additional 6 weeks. MRI scans and pain assessments will be conducted at baseline, after 6 weeks, and for some participants after 12 weeks to evaluate changes in brain connectivity, neuroinflammation, and pain symptoms. Participants will complete quality of life and pain questionnaires, as well as physical and functional tests at multiple timepoints during the study. Researchers will monitor brain imaging results using MRI, including spectroscopy for neuroinflammation markers. The total participation time is generally 7 weeks, extending to 13 weeks for some. The study will assess changes in pain severity, interference, and other patient-reported outcomes to better understand the effects of CES therapy on Gulf War Illness symptoms.
CONDITIONS
Brief Title
Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be male or female aged 40 to 80 years
- Must meet Gulf War Illness criteria based on CDC and Kansas definitions
- Must have daily pain rated 4 or higher on the Defense and Veterans Pain Rating Scale for over 90 days
- Must have intact, infection-free skin at the electrode placement site (earlobe)
- Must be willing to participate and understand the consent process
- Must be right-handed for brain structure consistency
You will not qualify if you...
- Currently pregnant individuals are excluded
- History of drug abuse or severe psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation
- Skin conditions like psoriasis vulgaris that increase infection risk at the electrode site
- Introduction of new medications or treatments during the study
- Severe anxiety, claustrophobia, or inability to remain still in an MRI scanner without sedation
- Presence of implanted electrical devices incompatible with MRI (e.g., pacemaker, vagal stimulator)
- History of seizures or neurological conditions altering brain structure
- Allergy to metals used in CES electrodes
- Diagnosed autoimmune diseases that better explain pain symptoms
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants are trained to use a cranial electrical stimulation (CES) device and instructed to use it each evening for 60 minutes over 6 weeks. This includes either true CES therapy or sham CES therapy.
Baseline visit and 1 visit at 6 weeks post-treatment including MRI assessments
Duration - 6 additional weeks
Participants initially randomized to sham CES who do not respond to treatment are offered true CES therapy for an additional 6 weeks with follow-up assessments.
1 follow-up visit at 12 weeks post-initial therapy including MRI and clinical assessments
Trial Site Locations
Total: 1 location
1
Emory Clinic
Atlanta, Georgia, United States, 30307
Actively Recruiting
Research Team
K
Katherine Egan, RN, CCRC
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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