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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
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
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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGRivermead Post Concussion Symptoms Questionnaire
RPQ, a validated measure of subjective global PCS symptoms.
Time frame: 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.
Time frame: 5 days
Rivermead Post Concussion Symptoms Questionnaire
RPQ, a validated measure of subjective global PCS symptoms.
Time frame: 1 month post-treatment
Montgomery-Åsberg Depression Rating Scale
Montgomery-Åsberg Depression Rating Scale is a widely used clinician-rated measure of depressive severity
Time frame: Baseline, post treatment day 5, and post treatment 1 month
Repeatable Battery for the Assessment of Neuropsychological Status
RBANS is a brief, individually administered battery to measure cognitive decline or improvement
Time frame: 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.
Time frame: 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.
Time frame: Baseline and post treatment 1 month
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