Post Concussion Syndrome
Conditions
Brief summary
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.
Interventions
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
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status. * At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation. * Onset of symptoms within 4 weeks following the head trauma. * Age 18-60, inclusive. * Persistence of PCS symptoms for at least 3 months but less than 12 months * Able to provide informed consent and comply with the study protocol * Patients will not be excluded solely on the basis of communication (i.e., non-English speaking) unless they have
Exclusion criteria
that is the cause of the communication difficulties.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post Concussion Symptoms Questionnaire | Baseline, change from baseline to immediately before the first iTBS treatment | RPQ, a validated measure of subjective global PCS symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale | Baseline, post treatment day 5, and post treatment 1 month | Montgomery-Åsberg Depression Rating Scale is a widely used clinician-rated measure of depressive severity |
| Repeatable Battery for the Assessment of Neuropsychological Status | Baseline and post treatment 1 month | RBANS is a brief, individually administered battery to measure cognitive decline or improvement |
| The Behavior Rating Inventory of Executive Function | Baseline, post treatment day 5, and post treatment 1 month | BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. |
| Headache Impact Test | Baseline and post treatment 1 month | 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. |
Countries
Canada
Contacts
Primary ContactSean Nestor, PhD, MD, FRCPC
Backup ContactMatthew Burke, MD, FRCPC
Outcome results
None listed