Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headach… (NCT04182659) | Clinical Trial Compass
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Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
United States150 participantsStarted 2019-10-01
Plain-language summary
This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.
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
* 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 Engl…
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 uses something called neuronavigation-guided rTMS to treat Gulf War Illness headaches and pain — can you explain how that brain stimulation approach works and whether my specific pattern of GWI symptoms, like muscle pain, joint pain, or headaches, seems like a reasonable match for what this study is targeting?
2The trial is listed as 'Phase NA' and its recruitment status is unknown, which makes me unsure whether it's still enrolling or even wrapping up — do you know if this study is still active and accepting participants, and how I'd find out if I'm eligible?
3The study is measuring changes in a lot of overlapping symptoms — fatigue, sleep, fibromyalgia, neurobehavioral issues, and multiple types of pain — so how do researchers typically determine whether an rTMS treatment is actually working versus just natural fluctuation in GWI symptoms over time?
4Since this involves repeated brain stimulation sessions guided by neuronavigation equipment, what does the actual treatment schedule look like in terms of visits and time commitment, and are there any known side effects from rTMS that would be worth weighing against staying on my current pain management approach?
5Given that standard care options exist for GWI-related headaches and pain, would you recommend I try those first before considering an experimental study like this, or do you think the potential benefits of this particular approach make it worth discussing sooner?
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 quality of life
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
5
Change from baseline to post treatment of body pain
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
6
Change from baseline to post treatment of muscle pain
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
7
Change from baseline to post treatment of fibromyalgia
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
8
Change from baseline to post treatment of neurobehavioral symptoms
Timeframe: The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
9
Change from baseline to post treatment of sleep quality
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
10
Change from baseline to post treatment of sleep difficulties
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month
11
Change from baseline to post treatment of fatigue
Timeframe: Baseline, 1-week, 1-month, 2-month, and 3-month