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TMS has been safely and reliably delivered at the Harquail Centre for over 5 years, with a primary focus on conventional rTMS protocols for treatment-resistant depression. Recently, the investgator team has gained the capability to deliver sham-controlled intermittent theta-burst stimulation (iTBS) rTMS. Unlike conventional high frequency rTMS, which was used in the previous sham-controlled rTMS PCS pilot study, iTBS is a patterned form of stimulation that recapitulates endogenous activity patterns of neural circuits pairing gamma frequency (50Hz) burst pulses coupled in a theta frequency rhythm (5Hz).12 iTBS delivers 600 pulses in just over 3 minutes with similar or greater effects on neural plasticity compared to conventional rTMS (taking over 30-45 minutes) and similar tolerability and efficacy in trials of depression. Furthermore, novel accelerated iTBS protocols stimulating the left dorsolateral prefrontal cortex (dlPFC) over 8-10 treatments, 50 minutes apart over a 5 day interval has recently demonstrated robust efficacy in depression and received recent FDA approval. Thus, accelerated iTBS can be delivered in a single week of treatment compared to 6 weeks with conventional rTMS methods. Finally, the investigators recently acquired the technology to integrate MRI neuroimage-guided stimulation, which would allow to target specific brain regions/networks implicated in PCS at high spatial resolution. No studies to date have investigated image-guided accelerated iTBS rTMS for the treatment of PCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Theta-Burst Stimulation | Device | Accelerated course of left dlPFC iTBS, consisting of 600 pulses/session, 50 minutes intersession interval, 8 session/day for 5 days) at 90% resting MT |
| Measure | Description | Time Frame |
|---|---|---|
| Rivermead Post Concussion Symptoms Questionnaire | RPQ, a validated measure of subjective global PCS symptoms. | Baseline, change from baseline to immediately before the first iTBS treatment |
| Rivermead Post Concussion Symptoms Questionnaire | RPQ, a validated measure of subjective global PCS symptoms. | 5 days |
| Rivermead Post Concussion Symptoms Questionnaire | RPQ, a validated measure of subjective global PCS symptoms. | 1 month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg Depression Rating Scale | Montgomery-Ã…sberg Depression Rating Scale is a widely used clinician-rated measure of depressive severity | Baseline, post treatment day 5, and post treatment 1 month |
| Repeatable Battery for the Assessment of Neuropsychological Status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Nestor, PhD, MD, FRCPC | Contact | 416-480-4085 | sean.nestor@sunnybrook.ca | |
| Matthew Burke, MD, FRCPC | Contact | 416-480-4216 | matthew.burke@sunnybrook.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N3M5 | Canada |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| Sham Intermittent Theta-Burst Stimulation | Device | Magventure Active/Placebo B70 coil specifically designed for randomized clinical trials with TMS. This system uses electrodes placed on the scalp to provide stimulation mimicking the active treatment condition |
|
RBANS is a brief, individually administered battery to measure cognitive decline or improvement |
| Baseline and post treatment 1 month |
| The Behavior Rating Inventory of Executive Function | BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. | Baseline, post treatment day 5, and post treatment 1 month |
| Headache Impact Test | HIT is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. | Baseline and post treatment 1 month |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |