Actively Recruiting
Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Led by Sunnybrook Health Sciences Centre · Updated on 2024-05-08
10
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The current study aims to better understand the efficacy of intermittent theta-burst stimulation (iTBS) treatment in patients diagnosed with post-concussion syndrome (PCS) and to explore changes in brain networks after undergoing iTBS to assess its safety and feasibility in treating PCS.
CONDITIONS
Official Title
Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented head trauma causing loss of consciousness, post-traumatic amnesia, or altered mental status
- At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, or mood dysregulation
- Symptoms started within 4 weeks after head trauma
- Age between 18 and 60 years, inclusive
- Post-concussion symptoms lasting at least 3 months but less than 24 months
- Able to provide informed consent and follow study procedures
- Communication difficulties alone (non-English speaking) do not exclude participation unless caused by exclusion criteria
You will not qualify if you...
- Major structural brain abnormalities on imaging (e.g., intracranial hemorrhage, skull fracture, large lesion)
- Previous treatment with repetitive transcranial magnetic stimulation (rTMS)
- Contraindications to MRI such as pacemaker or metallic implants
- Non-removable ferromagnetic metallic implants above the collarbone, except dental work
- Active personal injury legal cases
- History of seizure disorder (except childhood febrile seizures)
- Substance dependence within the last 6 months
- Pregnancy
- Taking more than 2 mg lorazepam daily (or equivalent benzodiazepine) or any dose of anticonvulsant medication
- Currently using antiepileptic medication
- Significant medical conditions as judged by investigators (e.g., neurological diseases, uncontrolled hypertension or diabetes, cancer)
- Major psychiatric disorders or psychosis at enrollment (e.g., schizophrenia, bipolar disorder)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
S
Sean M Nestor, MD
CONTACT
E
Erica S Reyvas, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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