Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome
ConditionGulf War Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorEmory University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cranial electrical/electrotherapy stimulation (CES)
- Sham Cranial electrical/electrotherapy stimulation (CES)
Treatment groups
130 Participants
are divided into 3 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov