Recruiting

Theta-burst Stimulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06398665

Conditions

Post-Concussion Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Intermittent Theta-Burst Stimulation

Study Details

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.

Conditions

Post-Concussion Syndrome

Study ID

NCT06398665

Start date

Apr 29, 2024

Status verified date

May, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated Intermittent Theta-Burst Stimulation

Non-invasive brain stimulation technique, accelerated intermittent theta-burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS), for treating post- concussive syndrome (PCS) in persons with mild traumatic brain injury

Interventions

Intermittent Theta-Burst Stimulation

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)

Primary outcome measure

  • Rivermead Post-Concussion Symptoms Questionnaire [ Time Frame: Baseline, immediately before the first iTBS treatment ]
  • Rivermead Post-Concussion Symptoms Questionnaire [ Time Frame: 5 days ]
  • Rivermead Post-Concussion Symptoms Questionnaire [ Time Frame: 1 month post-treatment ]

Central Contacts and Locations

Central contacts

Sean M Nestor, MD

416-480-4085sean.nestor@sunnybrook.ca

Erica S Reyvas, BA

416-480-4053erica.reyvas@sri.utoronto.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Sean M Nestor, MD

416-480-4085sean.nestor@sunnybrook.ca

Principal Investigator:

Sean M Nestor, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 8, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-05-08.