Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome

Not Applicable

Recruiting

• Conditions: Post Concussion Syndrome
• Interventions: Device: Intermittent Theta-Burst Stimulation; Device: Sham Intermittent Theta-Burst Stimulation

• Registration Number: NCT06031662
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-11
• Status Verified: 2023-10
• Study Start: 2023-10-31
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Intermittent Theta-Burst Stimulation	-
Sham	Sham Intermittent Theta-Burst Stimulation	-

Primary Outcome Measures

Name	Time	Method
Rivermead Post Concussion Symptoms Questionnaire	1 month post-treatment	RPQ, a validated measure of subjective global PCS symptoms.

Secondary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale	Baseline, post treatment day 5, and post treatment 1 month	Montgomery-Åsberg Depression Rating Scale is a widely used clinician-rated measure of depressive severity
Repeatable Battery for the Assessment of Neuropsychological Status	Baseline and post treatment 1 month	RBANS is a brief, individually administered battery to measure cognitive decline or improvement
The Behavior Rating Inventory of Executive Function	Baseline, post treatment day 5, and post treatment 1 month	BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
Headache Impact Test	Baseline and post treatment 1 month	HIT is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada