Cranial Electrotherapy Stimulation for Gulf War Syndrome

Overseen By Katherine Egan, RN, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Drug abuse, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores cranial electrotherapy stimulation (CES) to manage headaches and pain associated with Gulf War Illness. The researchers aim to understand how this non-drug treatment affects brain function and pain relief. Participants will use either the real CES device or a sham (inactive) version to compare results. The trial seeks individuals who have experienced daily pain for over 90 days and meet specific criteria related to Gulf War Illness symptoms, such as fatigue and joint pain. Participants must also have intact skin on their earlobes, where the device will be used. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for Gulf War Illness.

Will I have to stop taking my current medications?

The trial requires that you do not introduce new medications or treatments during the study, but it does not specify if you need to stop taking your current medications. It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that cranial electrotherapy stimulation is safe for treating Gulf War Syndrome?

Research has shown that Cranial Electrotherapy Stimulation (CES) is generally safe and well-tolerated. In past studies, participants reported only minor side effects. This finding suggests the treatment is safe for most people.

One study found that CES side effects are usually mild and temporary, such as slight skin irritation or dizziness, which often resolve quickly. This is encouraging for anyone considering CES, as the treatment does not seem to pose major safety concerns.

Overall, CES has been used for other conditions and has demonstrated a good safety record, indicating that people have used it without serious problems. While the current study aims to learn more about how CES works for Gulf War Illness, existing research supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cranial Electrotherapy Stimulation (CES) for treating Gulf War Syndrome because it offers a non-invasive approach that could potentially ease symptoms without the need for medication. Unlike the standard treatments, which often involve medications and psychotherapy, CES uses a gentle electrical current delivered through electrodes placed on the head, targeting the brain to help alleviate symptoms like pain, anxiety, and insomnia. This method is appealing because it avoids the side effects associated with drugs and might work faster, offering relief in just a few weeks. Plus, the ability to use CES at home makes it a convenient and accessible option for veterans seeking alternative treatments.

What evidence suggests that cranial electrotherapy stimulation is effective for Gulf War Syndrome?

Studies have shown that cranial electrotherapy stimulation (CES) might help with anxiety, trouble sleeping, and pain. This trial will evaluate CES for symptoms of Gulf War Illness, such as headaches. Participants will join either a true CES therapy group or a sham CES therapy group to compare effects. Research suggests that CES could enhance brain function, which relates to these symptoms. Although the results are promising, they remain limited, and more information is needed to confirm its effectiveness. CES might help balance brain activity and reduce pain signals, providing relief for those affected. ^{1 2 3 4 6}

Who Is on the Research Team?

Lisa C Krishnamurthy, PhD

Principal Investigator

Emory University 404-712-5332

Anna Woodbury, MD, MSc

Principal Investigator

Emory University 404-727-8463

Are You a Good Fit for This Trial?

This trial is for individuals with Gulf War Syndrome, specifically those experiencing headache and pain. Participants should be willing to undergo cranial electrical stimulation therapy and MRI scans. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Meet criteria for GWVI based on the CDC and Kansas Criteria for GWVI

Subjects must be willing to participate and understand the consent

Subjects must be right-handed to provide consistency in brain structure and function

Exclusion Criteria

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 introduce new medications or treatments for symptoms during the study to prevent confounding results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either true or sham CES therapy for 6 weeks, using the device each evening for 60 minutes

6 weeks

Baseline assessment and post-treatment assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI assessments

1 week

Post-treatment MRI assessment

Extension for Non-responders

Non-responders to sham CES are offered true CES therapy for an additional 6 weeks

6 weeks

Post-extension assessment

What Are the Treatments Tested in This Trial?

Interventions

• Cranial Electrotherapy Stimulation

Trial Overview The study tests the effectiveness of Alpha-Stim™ cranial electrical stimulation (CES) in treating symptoms of Gulf War Illness-related Headache and Pain (GWI-HAP). It uses an adaptive design and brain imaging via MRI to understand how CES affects brain function.

How Is the Trial Designed?

Group I: True CES therapy for non-responders Experimental Treatment 1 Intervention

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.

Group II: True CES therapy Experimental Treatment 1 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). The intervention (true CES) will occur over the course of 6 weeks.

Group III: Sham CES therapy Placebo Group 1 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). The intervention (sham CES) will occur over the course of 6 weeks.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/308222/cranial-electrotherapy-stimulation-and-brain-imaging-for-gulf-war-syndrome/

Cranial Electrotherapy Stimulation and Brain Imaging for ... This cranial electrical stimulation (CES) device has shown promising, though limited results for anxiety, insomnia, and pain. They also plan to ...

2. withpower.com withpower.com/trial/phase-persian-gulf-syndrome-8-2025-12bef

Cranial Electrotherapy Stimulation for Gulf War Syndrome Trial Overview The study tests the effectiveness of Alpha-Stim™ cranial electrical stimulation (CES) in treating symptoms of Gulf War Illness-related Headache ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK565209/

Results - Gulf War Illness: A Systematic Review of ... - NCBI Although CPAP is an evidence-based treatment for sleep apnea, CPAP was also associated with improvement among a broader range of GWI symptoms in this study than ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03542383

Treatment of Memory Disorders in Gulf War Illness With ... Administer 10 20-minute sessions of 1 mA anodal High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.

5. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/gulf-war-illness-REPORT.pdf

Gulf War Illness: A Systematic Review of Therapeutic ... CPAP improved overall physical health, pain, cognitive functioning, fatigue, mental health, and sleep quality in a small study of Veterans with ...

6. cdmrp.health.mil cdmrp.health.mil/gwirp/pdfs/GWIRP_Landscape_2020.pdf

GWIRP Landscape Department of Defense Gulf War Illness Research Program, March 2020. 26. • Transcranial Direct Current Stimulation for Pain Treatment of Gulf War Illness.