Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612437
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMS
Brief Summary:
The goal of this clinical trial is to identify the effect of different time intervals between continuous theta burst stimulation cTBS and intermittent theta burst stimulationiTBS on top of a standard robot-assisted training RAT for sensorimotor rehabilitation in patients with chronic stroke Using electroencephalography EEG to explore potential sensorimotor neuroplasticity underying stroke
Detailed Description:
Delivering Intermittent theta burst stimulation iTBS primed with continuous theta burst stimulation cTBS to the primary motor cortex M1 may enhance the facilitatory effect of iTBS on the stimulated M1 through metaplasticity Previous studies have verified the effectiveness of priming iTBS on improving motor rehabilitation in patients with stroke However the optimal time interval between cTBS and iTBS remains unknown The aim of this clinical trial is to identify the effect of different time intervals between cTBS and iTBS followed with a standard robot-assisted training RAT for sensorimotor rehabilitation in patients with chronic stroke Using electroencephalography EEG to explore potential sensorimotor neuroplasticity A three-arm randomized controlled trial RCT will be performed with an estimated total of 30 patients with chronic stroke All participants will be randomly allocated to receive 10-session intervention of different TBS protocols ie cTBS-3min interval-iTBS cTBS-10min interval-iTBS and cTBS-20min interval-iTBS delivered for 2-4 sessions per week lasting for 3-4 weeks All participants will receive a 20-minute standard RAT after each stimulation session Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores FMA-UE Secondary outcomes will be Action Research Arm Test ARAT kinematic outcomes generated during RAT as well as EEG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None