rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head
CompletedPhase 1, Phase 2NCT03691272
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Brief summary (from the registry)
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.
Study details
- Official title
- Treatment of Persistent Headache Attributed to Mild Traumatic Injury to the Head (PHATIH) in Patients With Persistent Post Concussion Symptoms (PPCS) Using Repetitive Transcranial Magnetic Stimulation (rTMS)
- Conditions
- Brain Injuries, Traumatic
- Concussion, Brain
- Headaches Chronic
- Headache
- Post-Traumatic Headache
- Mild Traumatic Brain Injury
- Transcranial Magnetic Stimulation
- Interventions
- Device: rTMS - Real Air Film Coil
- Device: rTMS - Sham Coil
- Sponsor
- University of Calgary
- Collaborators
- Hotchkiss Brain Institute, University of Calgary
- Start date
- 2017-04-15
- Primary completion
- 2018-09-30
- Sex
- All
- Age range
- from 16 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03691272