Evaluating Cranial Electrical Stimulation Therapy and Brain Imaging for Pain in Gulf War Illness A Randomized, Double-Blind, Sham-Controlled Study in Adults 40 to 80 Years Old

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.

Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome