CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
MRIother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04649749
NCT04649749N/ACompleted

Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury

Medical University of Vienna·observational·Posted Dec 2, 2020·Updated Sep 28, 2023

In Brief

An observational study evaluating MRI for Brachial Plexus Neuropathies and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 2, 2020
Enrollment StartOct 1, 2020
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.6 years ago

Interventions

MRIother

MRI scan