Post-Concussion Syndrome
Conditions
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.
Detailed description
This open-label pilot study aims to investigate the potential of a 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 (mTBI). PCS is characterized by symptoms like cognitive impairment, mood dysregulation, fatigue, and headaches, with limited treatment options. Previous research has indicated brain network dysfunction in mTBI patients and suggested the potential of conventional once daily high frequency rTMS for treating PCS symptoms. Our proposal builds on these findings by utilizing the expertise and resources of Sunnybrook's Harquail Centre for Neuromodulation, which has extensive experience in delivering rTMS and theta-burst stimulation for treatment-resistant depression. This pilot study will implement an accelerated iTBS rTMS protocol, offering shorter treatment duration, as well as MRI-guided stimulation for precise targeting. The investigators will also explore changes in brain function following rTMS using a technique called functional magnetic resonance imaging. The investigators ultimately aim to understand how iTBS may alter the post-concussive brain and the extent to which these changes may improve PCS.
Interventions
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)
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This open-label pilot study aims to investigate the potential of a 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 (mTBI).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post-Concussion Symptoms Questionnaire | Baseline, immediately before the first iTBS treatment | A validated measure of subjective global PCS symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale | Baseline, post treatment day 5, and Study endpoint | 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 | Repeatable Battery for the Assessment of Neuropsychological Status 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 | The Behavior Rating Inventory of Executive Function-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 | Headache Impact Test is a tool used to measure the impact headaches have on one's ability to function on the job, at school, at home and in social situations. |
Countries
Canada
Contacts
Primary ContactSean M Nestor, MD
Backup ContactErica S Reyvas, BA
Outcome results
None listed