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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT03030794
Eligibility Criteria:
Criteria for veterans with Gulf War Illness headaches and pain:
Inclusion Criteria:
* Male or female between ages 18-65
* CDC Criteria for GWI
* Kansas Criteria for GWI
* International Headache Society Criteria for Migraine HA w/o aura
* Average Headache Exacerbation Intensity \>3 on 0-10 NPRS
* Average Overall Daily Muscle Pain Intensity \>3 on 0-10 NPRS
* Average Overall Daily Extremities Joint Pain Intensity \>3 on 0-10 NPRS
* Headache Exacerbation/Attack ≥ 3 times/week, lasting \>4 hrs in past 3 months
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
Criteria for healthy veterans without Gulf War Illness headaches and pain:
Inclusion Criteria:
* Male or female between ages 18-65
* Served at least 30 consecutive days in the Persian Gulf between 8/90-7/91
Exclusion Criteria:
* CDC Criteria for GWI
* Kansas Criteria for GWI
* International Headache Society Criteria for Migraine HA w/o aura
* Average Headache Exacerbation Intensity \>3 on 0-10 NPRS
* Average Overall Daily Muscle Pain Intensity \>3 on 0-10 NPRS
* Average Overall Daily Extremities Joint Pain Intensity \>3 on 0-10 NPRS
* Headache Exacerbation/Attack ≥ 3 times/week, lasting \>4 hrs in past 3 months
* 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:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03030794
Study Brief:
Protocol Section:
NCT03030794