Last updated: May 6, 2024
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Active - Recruiting
Phase
N/A
Condition
Brain Injury
Treatment
Intermittent Theta-Burst Stimulation
Clinical Study ID
NCT06398665
6160
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Documented evidence of head trauma sufficiently severe to result in loss ofconsciousness, 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-Englishspeaking) unless they have exclusion criteria that is the cause of the communicationdifficulties.
Exclusion
Exclusion Criteria:
- Evidence of major structural neuroimaging abnormalities (e.g., intracranialhemorrhage, 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 theexception 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 anydose 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.
Study Design
Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Intermittent Theta-Burst Stimulation
Phase:
Study Start date:
April 29, 2024
Estimated Completion Date:
March 31, 2026
Study Description
Connect with a study center
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N3M5
CanadaActive - Recruiting
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