Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06031662
Status:
RECRUITING
Last Update Posted:
2023-11-02
First Post:
2023-06-20
Brief Title:
Accelerated Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
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
Status:
RECRUITING
Status Verified Date:
2023-10
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:
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 5Hz12 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 regionsnetworks 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:
None
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