rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head
Condition: Brain Injuries, Traumatic; Concussion, Brain; Headaches Chronic; Headache; Post-Traumatic Headache; Mild Traumatic Brain Injury; Transcranial Magnetic Stimulation
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Traumatic Headache; Post-Concussion Syndrome; Craniocerebral Trauma; Headache; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Demographic information will be collected two weeks prior to starting the study including
      age, sex, education, headache history, concussion history, past medical history, medication
      use, and family medical history. Headache history will be collected including frequency,
      severity, medication-use, type of headache, associated symptoms (i.e. neck pain, photophobia,
      phonophobia, nausea, vomiting) and headache triggers. Baseline questionnaires will be
      completed including headache intensity scale - 6 (HIT-6), Rivermead PPCS questionnaire,
      British Columbia post-concussion symptom inventory (BC-PSI), Montreal cognitive assessment
      (MoCA), quality of life after brain injury questionnaire (QOLIBRI), patient health
      questionnaire-9 (PHQ-9), generalized anxiety disorder scale-7 (GADS-7) and the post traumatic
      stress disorder checklist for DSM-5 (PCL-5). Patients will keep a two-week baseline headache
      diary before treatment, 2 weeks during treatment, 2 weeks following rTMS, and for 2 weeks at
      the 1, 3, and 6 month follow up assessments (total of 12 weeks). Patients will be reassessed
      at the completion of their rTMS treatment (day 14), and at 1, 3, and 6 months post-treatment.
      The questionnaires including: HIT-6, Rivermead PPCS questionnaire, PC-PSI, QOLIBRI, PHQ-9 and
      GAD-7 will be completed at all follow up visits.
    

Intervention name(s): rTMS - Real Air Film Coil; rTMS - Sham Coil
Intervention type(s): Device; Device
Intervention description(s): 70% resting motor threshold amplitude; Frequency 10 Hz; 10 trains of 60 pulses/train (total of 600 pulses); Inter-train interval 45s.; A sham coil will be applied to the scalp after the resting motor threshold is determined. Patients will be able to hear the sound and feel the vibration of sham coil, but will not experience any effective stimulation.
Other intervention name(s): Repetitive Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment