rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI) (NCT04046536) | Clinical Trial Compass
CompletedNot Applicable
rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)
United States204 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Rehabil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is completed — has the results data been published yet, and if so, did the rTMS treatment show any meaningful changes in pain, headaches, depression, or fatigue specifically in Gulf War Veterans?
2Since this trial was listed as Phase NA, meaning it may have been exploratory or a pilot study, how does that affect how much we can trust the safety and benefit findings compared to a larger Phase 2 or Phase 3 trial?
3The study tracked a wide range of symptoms including fibromyalgia, sleep quality, neurobehavioral symptoms, and fatigue — do you think my specific combination of symptoms lines up closely enough with what was being studied here for the results to be relevant to me?
4Are there standard-of-care treatments for Gulf War Illness or depression that I should consider trying first, or alongside, before looking at whether rTMS-based approaches like this one might be worth pursuing?
5Given that this trial focused specifically on Gulf War Veterans, are there any ongoing or upcoming rTMS studies for similar symptom clusters that I might be a candidate for, now that this one has completed enrollment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to post treatment of GWI-related pain and headaches
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
2
Change from baseline to post treatment of sensory and affective aspects of pain
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
3
Change from baseline to post treatment of headaches
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
4
Change from baseline to post treatment of depression
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
5
Change from baseline to post treatment of quality of life
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
6
Change from baseline to post treatment of body pain
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
7
Change from baseline to post treatment of muscle pain