Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398665
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-01
Brief Title:
Accelerated Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Image-guided Accelerated Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Sunnybrooks 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None