GAIN Symptoms: Post-traumatic Headache (NCT05857761) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
GAIN Symptoms: Post-traumatic Headache
Denmark62 participantsStarted 2023-08-28
Plain-language summary
The overall aim of the study is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent post-traumatic headache (PTH) with a direct impact on the ability to diagnose and manage PTH effectively. The investigators also aim to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS), a novel intervention on PTH.
Who can participate
Age range
18 Years – 60 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
. mTBI within the last 2 to 4 months according to the diagnostic criteria recommended by the WHO task force
. age ≥ 18 years at the time of mTBI
. Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score ≥ 3 (moderate or severe problem) for subitem headache and a diagnosis of persistent PTH attributed to mTBI according to ICHD-3.
. previous mTBI within the last 2 years years leading to PCS lasting ≥ 3 months. Additionally, for study 2 and 3,
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 no longer actively recruiting — does that mean there's any chance I could still be considered, or should we focus entirely on other options for managing my post-traumatic headaches?
2This study is measuring biomarkers in the blood alongside headache days — does that mean it involves blood draws, and if so, how often, and is that something you think would be manageable given my current condition after my concussion?
3The trial tracks headache days of moderate to severe intensity using a questionnaire and diary-style monitoring — what does that level of self-reporting commitment actually look like week to week, and do you think that's realistic for where I am right now?
4Since this trial is in a non-standard phase and seems focused on understanding and characterizing post-traumatic headache rather than testing a specific treatment, what would I actually gain by participating compared to pursuing standard care for my mTBI headaches right now?
5The study compares biomarker levels in mTBI patients to healthy controls — does that mean part of the study's goal is still figuring out the biology of post-traumatic headache, and how does that affect what's currently known about the best ways to treat it?
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 in the number of headache days of moderate to severe intensity
Timeframe: Prior to intervention compared to 1 month after end of treatment.
2
Changes in the concentration of biomarkers
Timeframe: Prior to rTMS intervention, immediately after rTMS intervention and 1 month after end of treatment
3
A comparison at baseline of the blood biomarker concentrations in the mTBI patients compared to healthy controls
Timeframe: Prior to rTMS intervention
4
Characterization of PTH headache phenotypes using a self-constructed headache questionaire.