ELECTRIG: Evaluating Effects of Cranial Electrical Stimulation Therapy With Responsive Imaging in Gulf War Illness Pain and Comorbid Symptoms
Emory University
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.
Description
Gulf War Veterans are disproportionately plagued by fibromyalgia-like symptoms including headaches, joint, and muscle pain, known as gulf war illness pain or GWI-HAP. Treatment options are limited, and the neurobiology of these symptoms is poorly understood. In this population, the investigators plan to test a portable, non-pharmacological, non-invasive therapy (Alpha-Stim™) that is FDA-cleared for anxiety, insomnia, and pain, and readily available for widespread implementation in the United States. This cranial electrical stimulation (CES) device has shown promising, though limited results f…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
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, cogniti…
Interventions
- DeviceCranial electrical/electrotherapy stimulation (CES)
Cranial electrical/electrotherapy stimulation (CES) is a non-pharmacological, portable, non-invasive intervention. Active research units will be locked at the specified amplitude and administer that amplitude of stimulation for 60 minutes therapy.
- DeviceSham Cranial electrical/electrotherapy stimulation (CES)
Sham research units will be locked into active sham mode which provides stimulation designed to provide the sensation of stimulation for only 5 minutes while continuing to count down for the remaining 55 minutes.
Location
- Emory ClinicAtlanta, Georgia