Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Post-Concussion SyndromeThe 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 to 60
Critères de participation
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 24 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 Criteria:
* 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.
Lieu de l'étude
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Sunnybrook Health Sciences Centre
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06398665