Status:
COMPLETED
rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Gulf War Illness
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study aims to look at the effectiveness of using repetitive transcranial magnetic stimulation (rTMS) in relieving pain and other co-morbid symptoms of Gulf War Illness.
Detailed Description
Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04046536
Start Date
October 1 2019
End Date
December 1 2025
Last Update
December 18 2025
Active Locations (3)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
2
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
3
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033