Using brain stimulation to relieve Gulf War Illness related headaches and pain
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
NA · Veterans Medical Research Foundation · NCT04182659
This study is testing whether a new brain stimulation treatment can help military veterans with Gulf War Illness find relief from their headaches and pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Veterans Medical Research Foundation (other) |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Trial ID | NCT04182659 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a non-invasive treatment for alleviating headaches and pain symptoms associated with Gulf War Illness (GWI). It targets military personnel who served in the Persian Gulf War and suffer from debilitating symptoms such as migraines and joint pain. The study compares the effects of rTMS against a sham treatment to assess its efficacy in improving patients' quality of life. Participants must meet specific criteria related to their military service and pain levels to be eligible for the study.
Who should consider this trial
Good fit: Ideal candidates are military veterans under 65 who served in the Persian Gulf War and meet specific criteria for Gulf War Illness and pain severity.
Not a fit: Patients who are pregnant or have a history of pacemaker implants or ferromagnetic materials in their bodies will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective non-pharmacological option for managing chronic pain in Gulf War veterans.
How similar studies have performed: Other studies have shown promising results with rTMS for various pain conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region * Center for Disease Control (CDC) Criteria for Gulf War Illness (GWI) * Kansas Criteria for GWI * International Headache Society Criteria for Migraine Headache without aura Average Headache Exacerbation Intensity \>3 on 0-10 a Numerical Pain Rating scale (NPS) * Average Overall Daily Muscle Pain Intensity \>3 on 0-10 a NPS * Average Overall Daily Extremities Joint Pain Intensity \>3 on 0-10 a NPS * Headache Exacerbation/attack 3 times per week with the average intensity \>3 on a 0-10 NPS, lasting \> 4 hours in the past three months * Hamilton Rating Scale of Depression (HRSD) \<14 based on the sum of scores for the first 17 items Exclusion Criteria: * Pregnancy * History of pacemaker implant * Any ferromagnetic (e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI * History of dementia, major psychiatric diseases, or life-threatening diseases * Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy * History of seizure * Pending litigation * Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy * Lack of ability to understand the experimental protocol and to adequately communicate in English * History of Traumatic Brain injury * Chronic Tension or Cluster Headache * Ongoing Cognitive Rehabilitation or Treatment of PTSD
Where this trial is running
Palo Alto, California and 2 other locations
- VA Palo Alto — Palo Alto, California, United States (RECRUITING)
- VA San Diego Healthcare System — San Diego, California, United States (RECRUITING)
- VA Atlanta — Decatur, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Albert Leung, M.D. — San Diego Veterans Healthcare System
- Study coordinator: Caleb Lopez, BS
- Email: caleb.lopez@va.gov
- Phone: 858-552-8585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gulf War Syndrome, Gulf War Illness, Headache, Muscle Pain, Joint Pain, rTMS, Transcranial Magnetic Stimulation