rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head (TOPiCS-rTMS)
Brain Injuries, Traumatic, Concussion, Brain, Headaches Chronic
About this trial
This is an interventional treatment trial for Brain Injuries, Traumatic
Eligibility Criteria
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
Sites / Locations
- University Of Calgary
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
rTMS- Real Air Film Coil
rTMS- Sham coil
Patient MR brain scans will be loaded and processed using the Brainsight TMS neuronavigation software and stereotaxic data for localization of the TMS stimulation site will be determined through a co-registration method between the TMS coil position and the projected site on the MR brain scan. The DLPFC will be located through MNI coordinates (-48, 20, 34). Electromyography (EMG) electrodes will be attached to the right abductor digiti minimi (ADM) muscle. The resting motor threshold (RMT) is determined as the minimal stimulation intensity required to elicit motor-evoked response of 50 microvolts peak-to-peak amplitude in at least 5 out of 10 consecutive trials of the ADM (contralateral to stimulation).
The same procedure for determining RMT as described above will be employed for the Sham Arm. However, a sham coil will be used when the treatment over the left DLPFC is applied.