Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Image-guided, Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Sunnybrook Health Sciences Centre
10 participants
Apr 29, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 24 months
- Able to provide informed consent and comply with the study protocol
Exclusion Criteria12
- 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.
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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 motor threshold (MT)
Locations(1)
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NCT06398665