Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649749
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-10-01
Brief Title:
Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Traumatic brachial plexus lesions may lead to permanent impairment of hand function despite brachial plexus surgery In selected cases the affected forearm can be amputated and replaced by a bionic hand It is unclear how cortical activation patterns change after the injury and after acquisition of the hand prosthesis considering the complex changes in sensory and motor feedback The aim of the study is to measure cortical activity with fMRI during actual and imagery movements with the affected and healthy arm in a group of patients after traumatic brachial plexus injury and a group in whom this was followed by replacement with a bionic hand In this prospective study three groups of patients will participate 1 3 adult patients with a traumatic brachial plexus lesion eligible for a bionic arm but prior to its acquisition 2 3 patients with a traumatic brachial plexus lesion who have acquired the bionic arm already and 3 10 healthy subjects The investigators will measure cortical activity using fMRI BOLD tasks of closing the hand and motor imagery of this movement Cortical activity will be compared between the three groups Additionally regional gray matter volume resting-state and DTI networks will be studied Written informed consent will be provided prior to the investigation The complete examination has a duration of approximately 45 minutes
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