Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT04182659
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04182659
Study Brief:
Protocol Section:
NCT04182659