Recruiting

Theta-burst Stimulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06031662

Conditions

Post Concussion Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Intermittent Theta-Burst Stimulation

Sham Intermittent Theta-Burst Stimulation

Study Details

Brief summary:

TMS has been safely and reliably delivered at the Harquail Centre for over 5 years, with a primary focus on conventional rTMS protocols for treatment-resistant depression. Recently, the investgator team has gained the capability to deliver sham-controlled intermittent theta-burst stimulation (iTBS) rTMS. Unlike conventional high frequency rTMS, which was used in the previous sham-controlled rTMS PCS pilot study, iTBS is a patterned form of stimulation that recapitulates endogenous activity patterns of neural circuits pairing gamma frequency (50Hz) burst pulses coupled in a theta frequency rhythm (5Hz).12 iTBS delivers 600 pulses in just over 3 minutes with similar or greater effects on neural plasticity compared to conventional rTMS (taking over 30-45 minutes) and similar tolerability and efficacy in trials of depression. Furthermore, novel accelerated iTBS protocols stimulating the left dorsolateral prefrontal cortex (dlPFC) over 8-10 treatments, 50 minutes apart over a 5 day interval has recently demonstrated robust efficacy in depression and received recent FDA approval. Thus, accelerated iTBS can be delivered in a single week of treatment compared to 6 weeks with conventional rTMS methods. Finally, the investigators recently acquired the technology to integrate MRI neuroimage-guided stimulation, which would allow to target specific brain regions/networks implicated in PCS at high spatial resolution. No studies to date have investigated image-guided accelerated iTBS rTMS for the treatment of PCS.

Conditions

Post Concussion Syndrome

Study ID

NCT06031662

Start date

Oct 31, 2023

Status verified date

Oct, 2023

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

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 12 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

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

sham comparator: Sham

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 MT

Sham Intermittent Theta-Burst Stimulation

Magventure Active/Placebo B70 coil specifically designed for randomized clinical trials with TMS. This system uses electrodes placed on the scalp to provide stimulation mimicking the active treatment condition

Primary outcome measure

  • Rivermead Post Concussion Symptoms Questionnaire [ Time Frame: Baseline, change from baseline to 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 Nestor, PhD, MD, FRCPC

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

Matthew Burke, MD, FRCPC

416-480-4216matthew.burke@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Sean Nestor, PhD MD FRCPC

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

Principal Investigator:

Sean Nestor, PhD MD FRCPC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Nov 2, 2023

Last verified

Oct, 2023

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 2023-11-02.