Using rTMS to relieve pain and symptoms in Gulf War veterans
rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI
This study is testing if a non-invasive treatment called rTMS can help relieve pain and other symptoms in Gulf War veterans suffering from Gulf War Illness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Trial ID | NCT04046536 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a non-invasive treatment for alleviating pain and co-morbid symptoms associated with Gulf War Illness (GWI) in veterans. It focuses on common debilitating symptoms such as headaches and muscle/joint pain, which affect a significant portion of Gulf War veterans. The study aims to provide an alternative to conventional pharmacological treatments that have shown limited effectiveness and potential side effects. Participants will receive either active rTMS or sham treatment to assess the outcomes.
Who should consider this trial
Good fit: Ideal candidates are Gulf War veterans under 65 years old who meet specific criteria for Gulf War Illness and experience chronic pain and depression.
Not a fit: Patients with a history of major psychiatric diseases, dementia, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide Gulf War veterans with a new, effective option for managing pain and associated symptoms without the drawbacks of traditional medications.
How similar studies have performed: Other studies have shown promise with rTMS for various pain conditions, suggesting potential for success in this novel application for Gulf War veterans.
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 * CDC Criteria for GWVI (GWI) * Kansas Criteria for GWVI (GWI) * International Headache Society Criteria for Migraine Headache without aura * 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 once a week with the average intensity \>3 on a 0-10 NPS, lasting \> 1 hour in the past three months * Hamilton Rating Scale of Depression (HRSD) greater than or equal to 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 Health Care System, Palo Alto, CA — Palo Alto, California, United States (Recruiting)
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Albert Yick Leung, MD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Caleb T 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.