Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05165472
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2021-12-07
Brief Title:
Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
TRAINCP
Brief Summary:
Unilateral spastic cerebral palsy USCP leads to life-long impairment with a hemiparesis of the affected side of the body Rehabilitation efforts combine evidence based methods such as constrained induced movement therapy CIMT or hand-arm bimanual intensive therapy HABIT as well as training in daily life activities and psychological support in order to improve participation It has been tried to enhance hand motor function trainings with non-invasive brain stimulation However evidence of this promising approach is limited This might be due to a non-consideration of the individually different types of cortico-spinal projections to the paretic hand that demonstrated to be of highly relevant for the therapy of these children Approximately one third of such patients control their paretic hands via crossed projections from the affected hemisphere CONTRA while one third uses ipsilateral projections from the contralesional hemisphere IPSI This study aims - for the first time - to enhance the effects of the training by priming the primary motor cortex M1 of the paretic hand with a newly established high frequency quadri-pulse theta burst stimulation qTBS in a randomized patient and evaluator blind sham-controlled approach for the first time taking the individual type of cortico-spinal reorganization CONTRA vs IPSI into account This promising and neurophysiologically motivated approach is likely to ameliorate hand function in children with USCP
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