Gulf War SyndromeNCT07151248
Cranial Electrotherapy Stimulation and Brain Imaging for Gulf War Syndrome
A study testing Cranial electrical/electrotherapy stimulation (CES) in people with Gulf War Syndrome, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Gulf War Syndrome
- What is being tested?
- Cranial electrical/electrotherapy stimulation (CES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Subjects 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 perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
- Subjects 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.
Show all 9Show fewer
- Subjects must not have a history of seizures or neurologic conditions that may alter the structure of the brain.
- Subjects must not be allergic to the metals used in electrodes for CES stimulation.
- Subjects must not have a diagnosed autoimmune disease that better explains pain symptoms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory Clinic
Atlanta, Georgia, 30307
Katherine Egan, RN, CCRC, 404-727-8463, kfegan@emory.edu
About this study
Official title: ELECTRIG: Evaluating Effects of Cranial Electrical Stimulation Therapy With Responsive Imaging in Gulf War Illness Pain and Comorbid Symptoms
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.
Read the detailed 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 for anxiety, insomnia, and pain. They also plan to employ magnetic resonance spectroscopy (MRS) to evaluate neuroinflammation.
Subjects will be male and females, age 40-80 years old, with a diagnosis of Gulf war illness. Subjects will be recruited by referral and posted flyers on Emory campus, ResearchMatch, the Gulf War Registry, and the Wounded Warriors' Program. The research team will not approach vulnerable populations including minors, prisoners, pregnant persons, neonates or human fetuses, wards of the state, or cognitively impaired persons. Recruitment, screening and enrollment will occur at the Emory clinics (EUHM and EUH) and the Human Subjects Research Building II.
This randomized, double-blind, sham-controlled study will compare the efficacy of "active" or true CES therapy to "sham" CES therapy. Participants will be randomized in a 1:1 ratio to true or sham CES (n=104 total; 52 true, 52 sham). Up to 130 subjects will be enrolled to achieve 104 treated subjects. Baseline assessments including quality of life questionnaires and pain assessments, in addition to MRI will be obtained prior to initiation of the intervention.
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). They will also be provided detailed instructions.
The intervention (both sham and true CES) will occur over the course of 6 weeks, and participants will be assessed again post-treatment. To assess our neuroimaging outcomes, MRI will also be obtained at 6 weeks post-treatment, to assess for changes in connectivity and neuroinflammation. The total time commitment for most subjects will be 7 weeks.
Participants who are initially randomized to sham and are determined to be non-responders (<2 point decrease on DVPRS) will be offered the opportunity to utilize the true CES therapy with additional reimbursement and follow-up periods. They will use the device for an additional 6 weeks and return for post-treatment follow up at that time (12 weeks after initial therapy) that will include additional MRI and the original baseline and 6-week assessments. The total time commitment for these subjects will be 13 weeks.
A verbal prescreening consent will be used to confirm eligibility. Informed consent will be conducted in person with the participant and written, or over the telephone or zoom with consent signed using Hipaa Part 11 compliant DocuSign. Participants may also consent to be contacted for future research.
- Conditions
- Gulf War Syndrome
- Being tested
- Cranial electrical/electrotherapy stimulation (CES), Sham Cranial electrical/electrotherapy stimulation (CES)
- Keywords
- Gulf War Illness Headaches and Pain
- Medical subject headings
- Persian Gulf Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial electrical/electrotherapy stimulation (CES)Device
Also called CES, Alpha-Stim™
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.
Sham Cranial electrical/electrotherapy stimulation (CES)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| True CES therapy | Experimental | 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. Receives: Device: Cranial electrical/electrotherapy stimulation (CES) |
| Sham CES therapy | Sham comparator | 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. Receives: Device: Sham Cranial electrical/electrotherapy stimulation (CES) |
| True CES therapy for non-responders | Experimental | 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. Receives: Device: Cranial electrical/electrotherapy stimulation (CES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 and 12 weeks post-intervention
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.
Measured: Baseline, 6 and 12 weeks post-intervention
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.
Measured: Baseline, 6 and 12 weeks post-intervention
Secondary outcomes (17)
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.
Measured: Baseline, 6 and 12 weeks post-intervention
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.
Measured: Baseline, 6 and 12 weeks post-intervention
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.
Measured: Baseline, 6 and 12 weeks post-intervention
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.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Patient-Reported Outcomes Measurement Information System (PROMIS): sleep score
This measure focuses on the past seven days and assesses perceived difficulties with sleep onset, sleep continuity, and overall sleep quality.
It includes a 5-point Likert scale (1=never to 5=always) for each item. Raw scores are summed, and then converted to T-scores, where 50 represents the average for the U.S. general population, and a standard deviation of 10. Higher T-scores represent better health.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS: social isolation score
This measure focuses on the past seven days and assesses perceived difficulties with social isolation.
The measure use a 5-point Likert scale (1=never to 5=always) for a total of 4 items item. Total possible score range from 4-20 with lower score correlating with better study outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS: alcohol use score
This measure focuses on the past seven days and assesses perceived difficulties with alcohol use.
The measure use a 5-point Likert scale (1=never to 5=always) for a total of 37 items item. Total possible score range from 37-185 with lower score correlating with better study outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS: global health score
This measure focuses on the past seven days and assesses perceived difficulties with global health.
The measure use a 5-point Likert scale (1=never to 5=always) for a total of 9 items item. Total possible score range from 9-45 with lower score correlating with better study outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS 29 score
PROMIS-29 involves assessing responses on a 1-5 scale (or 0-10 for pain intensity), then averaging responses within each of the seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) to create a raw score for that domain. These raw scores are transformed into T-scores, with a mean of 50 and a standard deviation of 10, to indicate health status relative to a reference population, where higher T-scores represent better health.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in SF-36 score from baseline
SF-36 is a multi-purpose, short-form health survey developed for assessing health-related quality of life. It measures eight health concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to personal or emotional problems, and mental health.
Each scale score has a possible score range 0-100 scale, where 0 represents the worst possible health state and 100 represents the best.
The scores for the items that contribute to each scale are averaged to produce a total score for the scale (possible range 0-100), higher score represents better outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Resting-State fMRI Connectivity measured with Seed-Based Functional Connectivity Analysis
This outcome assesses changes in functional connectivity within brain function networks relevant to chronic pathology through Pearson correlation between fMRI signal in relevant seed regions of interest. Higher FC within impaired brain function networks (e.g., fronto-temporal) and lower FC within abnormally enhanced (pain expression) represent better outcomes.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Resting-State fMRI Connectivity measured with Independent Components Analysis
This outcome assesses changes in functional connectivity within the brain and between brain function networks relevant to chronic pathology. Independent Components Analysis (ICA) measures resting state network (IC) connectivity strength (expressed as z-sore) and between functional network connectivity (FNC). Higher IC strength within impaired brain function networks (e.g., fronto-temporal) and lower IC strength within abnormally enhanced (pain expression) represent better outcomes. Higher FNC in beneficent inter-network connections (e.g., between fronto-striatal and limbic networks) and lower FNC in malignant inter-network connections (e.g., default mode and pain expression networks) represent better outcomes.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: lactate
This outcome assesses changes in brain neurochemical composition across the study period.
Magnetic Resonance Spectroscopy (MRS) will be used to measure water-scaled, tissue-corrected concentrations of lactate. Reductions in lactate represents better outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: N-acetyl aspartate (NAA)
Magnetic Resonance Spectroscopy (MRS) will be used to measure water-scaled, tissue-corrected concentrations of N-acetyl aspartate (NAA). Reductions in NAA represents better outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: choline
Magnetic Resonance Spectroscopy (MRS) will be used to measure water-scaled, tissue-corrected concentrations of choline. Reductions in choline represent better outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: tCr
Magnetic Resonance Spectroscopy (MRS) will be used to measure water-scaled, tissue-corrected concentrations of total creatine (tCr). A decrease in tCr concentration, represents better outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolites: Ratio of NAA/tCr
Ratio of NAA/tCr will also be quantified, as a decreased ratio of NAA/tCr has been linked to mitochondrial dysfunction in ill Gulf War Veterans. An increase in NAA/tCr ratio, represents better outcome.
Measured: Baseline, 6 and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start26 Sep 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, sham-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Anna Woodbury, Emory University
- Investigators
- Anna Woodbury, MD, MSc, Principal investigator, Emory University 404-727-8463Lisa C Krishnamurthy, PhD, Principal investigator, Emory University 404-712-5332
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151248
- Sponsor's protocol ID
- STUDY00009810
- Other IDs
- 2025P011630, CDMRP-TX240208, CDMRP-TX240208P1
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Neuroimaging data (de-identified) will be shared for use in ENIGMA as part of the Chronic Pain Working Group Clinical outcomes (de-identified) for correlation with neuroimaging data Data may also be shared with the DOD and with other investigators
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECTRIG: Evaluating Effects of Cranial Electrical Stimulation Therapy With Responsive Imaging in Gulf War Illness Pain and Comorbid Symptoms
- ClinicalTrials.gov ID
- NCT07151248
- Acronym / sponsor ID
- STUDY00009810
- Conditions
- Gulf War Syndrome
- Keywords
- Gulf War Illness Headaches and Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 for anxiety, insomnia, and pain. They also plan to employ magnetic resonance spectroscopy (MRS) to evaluate neuroinflammation.
Subjects will be male and females, age 40-80 years old, with a diagnosis of Gulf war illness. Subjects will be recruited by referral and posted flyers on Emory campus, ResearchMatch, the Gulf War Registry, and the Wounded Warriors' Program. The research team will not approach vulnerable populations including minors, prisoners, pregnant persons, neonates or human fetuses, wards of the state, or cognitively impaired persons. Recruitment, screening and enrollment will occur at the Emory clinics (EUHM and EUH) and the Human Subjects Research Building II.
This randomized, double-blind, sham-controlled study will compare the efficacy of "active" or true CES therapy to "sham" CES therapy. Participants will be randomized in a 1:1 ratio to true or sham CES (n=104 total; 52 true, 52 sham). Up to 130 subjects will be enrolled to achieve 104 treated subjects. Baseline assessments including quality of life questionnaires and pain assessments, in addition to MRI will be obtained prior to initiation of the intervention.
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). They will also be provided detailed instructions.
The intervention (both sham and true CES) will occur over the course of 6 weeks, and participants will be assessed again post-treatment. To assess our neuroimaging outcomes, MRI will also be obtained at 6 weeks post-treatment, to assess for changes in connectivity and neuroinflammation. The total time commitment for most subjects will be 7 weeks.
Participants who are initially randomized to sham and are determined to be non-responders (<2 point decrease on DVPRS) will be offered the opportunity to utilize the true CES therapy with additional reimbursement and follow-up periods. They will use the device for an additional 6 weeks and return for post-treatment follow up at that time (12 weeks after initial therapy) that will include additional MRI and the original baseline and 6-week assessments. The total time commitment for these subjects will be 13 weeks.
A verbal prescreening consent will be used to confirm eligibility. Informed consent will be conducted in person with the participant and written, or over the telephone or zoom with consent signed using Hipaa Part 11 compliant DocuSign. Participants may also consent to be contacted for future research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind, sham-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| True CES therapy | Experimental | Device: Cranial electrical/electrotherapy stimulation (CES)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 CES therapy | Sham comparator | Device: Sham Cranial electrical/electrotherapy stimulation (CES)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. |
| True CES therapy for non-responders | Experimental | Device: Cranial electrical/electrotherapy stimulation (CES)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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be male and female age 40-80 years old
- Meet criteria for GWVI based on the CDC and Kansas Criteria for GWVI.
- 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.
Key exclusion criteria (9 listed)
- 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.
- Subjects 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 perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial electrical/electrotherapy stimulation (CES)Also: CES, Alpha-Stim™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. | Device | True CES therapy, True CES therapy for non-responders |
| Sham 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. | Device | Sham CES therapy |
Primary outcome
Change in Defense and Veterans Pain Rating Scale (DVPRS) from baseline
Time frame: Baseline, 6 and 12 weeks post-intervention
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.
Change in Brief Pain Inventory (BPI) severity subscale from baseline
Time frame: Baseline, 6 and 12 weeks post-intervention
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.
Change in Brief Pain Inventory (BPI) pain interference subscale from baseline
Time frame: Baseline, 6 and 12 weeks post-intervention
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.
17 secondary outcomes
Change in sit-to-stand/chair stand test
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in bicep(arm) curls
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in handgrip strength
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in finger-tap test
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Patient-Reported Outcomes Measurement Information System (PROMIS): sleep score
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS: social isolation score
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS: alcohol use score
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS: global health score
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in PROMIS 29 score
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in SF-36 score from baseline
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Resting-State fMRI Connectivity measured with Seed-Based Functional Connectivity Analysis
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Resting-State fMRI Connectivity measured with Independent Components Analysis
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: lactate
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: N-acetyl aspartate (NAA)
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: choline
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolite: tCr
Time frame: Baseline, 6 and 12 weeks post-intervention
Change in Magnetic Resonance Spectroscopy Metabolites: Ratio of NAA/tCr
Time frame: Baseline, 6 and 12 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. Neuroimaging data (de-identified) will be shared for use in ENIGMA as part of the Chronic Pain Working Group Clinical outcomes (de-identified) for correlation with neuroimaging data Data may also be shared with the DOD and with other investigators
Related trials for Gulf War Syndrome
Not yet recruiting
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome
Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Gulf War Syndrome, Adult Growth Hormone Deficiency
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Woodbury, MD, MSc principal investigator
Emory University 404-727-8463
Lisa C Krishnamurthy, PhD principal investigator
Emory University 404-712-5332
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial electrical/electrotherapy stimulation (CES) in people with Gulf War Syndrome, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Egan, RN, CCRC (404-727-8463, kfegan@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Defense and Veterans Pain Rating Scale (DVPRS) from baseline (time frame: Baseline, 6 and 12 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.