Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment
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Device: Intermittent Theta-Burst Stimulation
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
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| Sham Comparator: Sham
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Device: Sham Intermittent Theta-Burst Stimulation
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
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Outcome Measures
Primary Outcome Measures
- 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.
- Rivermead Post Concussion Symptoms Questionnaire [5 days]
RPQ, a validated measure of subjective global PCS symptoms.
- Rivermead Post Concussion Symptoms Questionnaire [1 month post-treatment]
RPQ, a validated measure of subjective global PCS symptoms.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status.
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At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation.
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Onset of symptoms within 4 weeks following the head trauma.
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Age 18-60, inclusive.
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Persistence of PCS symptoms for at least 3 months but less than 12 months
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Able to provide informed consent and comply with the study protocol
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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.
Exclusion Criteria:
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Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion)
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History of prior rTMS therapy,
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Contraindications to MRI (e.g., pacemaker, metallic implants etc.).
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Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work.
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Active personal injury litigation
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History of seizure disorder, not including febrile seizures in childhood
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Substance dependence within the last 6 months
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Pregnant
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Currently taking more than lorazepam 2 mg daily (or benzodiazepine equivalent) or any dose of an anticonvulsant (due to the potential to reduce rTMS efficacy)
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Currently taking an antiepileptic medication
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Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy)
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A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5821