NCT06398665 Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
| NCT ID | NCT06398665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Post-Concussion Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-04-29 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06398665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Post-Concussion Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398665 currently recruiting?
Yes, NCT06398665 is actively recruiting participants. Contact the research team at sean.nestor@sunnybrook.ca for enrollment information.
Where is the NCT06398665 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06398665 clinical trial?
NCT06398665 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 10 participants.