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New treatment option for Gulf War Syndrome
Official title Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome
ClinicalTrials.gov ID: NCT07151248
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- people 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...
- Kansas: 3 of 6 domains: 1) fatigue and sleep problems 2) pain symptoms 3) neurologic, cognitive, or mood symptoms 4) gastrointestinal symptoms 5)...
- people must self-report consistent, daily pain (greater than or equal to 4 on the DVPRS) \>90 days (prior to enrollment)
You likely can't join if
- people must not be currently pregnant since effects of fMRI and electrical current on the developing fetus are not well-known.
- people must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with...
- people must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
- people must not introduce new medications or treatments for symptoms during the study to prevent confounding results.
- people must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will...
- people must not have an implanted electrical device such as a surgically placed vagal stimulator, pacemaker, or spinal pain pump, which are not...
See the full eligibility criteria
- people 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...
- 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...
- people must self-report consistent, daily pain (greater than or equal to 4 on the DVPRS) \>90 days (prior to enrollment)
- people must have intact skin free of infection at the site of electrode placement (earlobe).
- people must be willing to participate and understand the consent.
- people must be right-handed to provide consistency in brain structure and function.
- people must not be currently pregnant since effects of fMRI and electrical current on the developing fetus are not well-known.
- people must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
- people must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
- people must not introduce new medications or treatments for symptoms during the study to prevent confounding results.
- people must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own...
- people must not have an implanted electrical device such as a surgically placed vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
- people must not have a history of seizures or neurologic conditions that may alter the structure of the brain.
- people must not be allergic to the metals used in electrodes for CES stimulation.
- people must not have a diagnosed autoimmune disease that better explains pain symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.