ELECTRIG: Evaluating Effects of Cranial Electrical Stimulation Therapy With Responsive Imaging in Gulf War Illness Pain and Comorbid Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Subjects must be male and female age 40-80 years old

• 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, cognitive, or mood symptoms 4) gastrointestinal symptoms 5) respiratory symptoms 6) skin symptoms chronic since 1990. Symptom reporting must be in the absence of diagnosed exclusionary conditions; only respondents who have at least 1 moderately severe symptom or 2 or more symptoms within a group were considered to have a high level of symptoms in the group.

• 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.

Locations
United States
Georgia
Emory Clinic
RECRUITING
Atlanta
Contact Information
Primary
Gretchen Windsor
gretchen.debaun.windsor@emory.edu
404-712-9907
Backup
Katherine Egan, RN, CCRC
kfegan@emory.edu
404-727-8463
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2029-09
Participants
Target number of participants: 130
Treatments
Experimental: True CES therapy
The participant will be trained in device usage and instructed to use the device each evening around the same time for 60 minutes (timer will be pre-set). The intervention (true CES) will occur over the course of 6 weeks.
Sham_comparator: Sham CES therapy
The participant will be trained in device usage and instructed to use the device each evening around the same time for 60 minutes (timer will be pre-set). The intervention (sham CES) will occur over the course of 6 weeks.
Experimental: True CES therapy for non-responders
For the non-responders (\<2 point decrease on DVPRS), the blind will be broken, and those non-responder participants who were initially assigned to sham placebo CES during the first 6 weeks of the intervention, now will be offered the opportunity to utilize the true CES device in a modified sequential parallel comparison design for an additional 6 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Emory University

This content was sourced from clinicaltrials.gov