Status:
UNKNOWN
Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Post Concussion Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
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 te...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion)
- History of prior rTMS therapy,
- Contraindications to MRI (e.g., pacemaker, metallic implants etc.).
- Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work.
- Active personal injury litigation
- History of seizure disorder, not including febrile seizures in childhood
- Substance dependence within the last 6 months
- Pregnant
- 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)
- Currently taking an antiepileptic medication
- Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy)
- A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06031662
Start Date
October 31 2023
End Date
August 1 2025
Last Update
November 2 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5