rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic I… (NCT03691272) | Clinical Trial Compass
CompletedPhase 1/2
rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head
Canada20 participantsStarted 2017-04-15
Plain-language summary
The objective of this study is to investigate the treatment effect of repetitive transcranial magnetic stimulation in patients with a history of both persistent post-traumatic headache and post-concussion symptoms. In this double-blind, sham-controlled, concealed allocation, randomized clinical trial, 20 patients aged 18-65 yrs will be recruited from the Calgary Brain Injury Program (CBIP) and the Calgary Headache Assessment and Management Program (CHAMP) / Calgary Chronic Pain Centre, Calgary, Alberta, Canada. Patients will engage in a two-week rTMS treatment protocol (10 treatments) and will be followed for 6 months after therapy.
Who can participate
Age range
16 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:
* Diagnosis of a persistent headache attributed to traumatic injury to the head based on the ICHD-3 criteria
* Diagnosis of persistent post-concussion symptoms based on the ICD-10 criteria
* mTBI occurrence from 3 months to 5 years from study start date
Exclusion Criteria:
* Prior history of TMS therapy
* TMS-related contraindications (pacemaker, metallic implant)
* History of chronic headache (\>15 days/month for 3 months) or migraine prior to most recent trauma
* Other medical conditions such as: structural brain disease, previous seizure, psychotic disorders (schizophrenia, bipolar disorder), liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and pregnancy
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 used repetitive Transcranial Magnetic Stimulation (rTMS) for post-traumatic headaches after a mild TBI — given that it was a Phase 1/2 study, what does that mean for how much we actually know about whether it's safe and effective compared to treatments I could try right now?
2The trial measured changes in headache severity and frequency at one month after treatment — is one month long enough to know if the benefits would last for someone in my situation, and are there any follow-up results beyond that timeframe that you're aware of?
3Since this trial is now completed, do you know if the results have been published, and if so, what did they actually show about whether rTMS helped reduce post-concussion headaches?
4Are there standard treatments for post-traumatic headache after mild TBI that I should consider trying first before exploring something like rTMS, or would rTMS fit into my care plan alongside those options?
5Given that this trial specifically focused on persistent headache as the main outcome, would rTMS be worth discussing for my other post-concussion symptoms too, or is the evidence mostly limited to headache relief?
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 headache severity from baseline to 1 month post-treatment.