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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cranial electrical/electrotherapy stimulation (CES)
DeviceCranial 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.
Sham Cranial electrical/electrotherapy stimulation (CES)
DeviceSham 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.
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: True CES therapyExperimental treatment 1 intervention
Group B: Sham CES therapySham comparator 1 intervention
Group C: True CES therapy for non-respondersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Defense and Veterans Pain Rating Scale (DVPRS) from baseline
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool. Patients will rate their pain intensity on a scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain.
Time frame
Baseline, 6 and 12 weeks post-intervention2
Change in Brief Pain Inventory (BPI) severity subscale from baseline
The BPI assesses pain severity and interference with function. The pain severity subscale consists of 4 items, each rated on a 0-10 numerical scale (0 = "no pain," 10 = "pain as bad as you can imagine"). Scores are averaged to yield a total range of 0-10. Lower scores reflect less severe pain and are considered favorable outcomes.
Time frame
Baseline, 6 and 12 weeks post-intervention3
Change in Brief Pain Inventory (BPI) pain interference subscale from baseline
The pain interference subscale consists of 7 items rated on a 0-10 numerical scale (0 = "does not interfere," 10 = "completely interferes"), assessing the impact of pain on daily activities such as mood, walking ability, work, and enjoyment of life. Scores are averaged to create a total range of 0-10. Lower scores reflect less interference from pain and are considered favorable outcomes.
Time frame
Baseline, 6 and 12 weeks post-interventionSecondary outcomes
1
Change in sit-to-stand/chair stand test
It involves repeatedly standing up and sitting down from a chair for a set period (30 seconds). The number of complete repetitions within the time limit is recorded.
Time frame
Baseline, 6 and 12 weeks post-intervention2
Change in bicep(arm) curls
The test involves having the individual perform as many controlled arm curls as possible within a 30-second timeframe. The total number of controlled repetitions within the 30-second period is recorded.
Time frame
Baseline, 6 and 12 weeks post-intervention3
Change in handgrip strength
Involves using a hand-held dynamometer to measure the maximum force exerted when squeezing the device. Maximun strength will be recorded.
Time frame
Baseline, 6 and 12 weeks post-intervention4
Change in finger-tap test
The Finger Tapping Test (FTT) is a physical function assessment used to evaluate motor speed and coordination. It's a simple test where a person taps their index finger against their thumb as quickly as possible for a set period, often 10 seconds, and the number of taps is recorded.
Time frame
Baseline, 6 and 12 weeks post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov