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

September 27, 2023 updated by: Galia Valentinova Anguelova, Medical University of Vienna
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A group of 3 adult patients who acquired a bionic hand at the Medical University of Vienna after a traumatic brachial plexus lesion, and a group of 3 patients eligible for the bionic hand prior to a possible amputation will be included. The number of patients included is based on the rarity of the procedure and thus the very limited number of eligible study participants. Ten control subjects will be included for comparison.

Description

Inclusion Criteria:

  • age above 18 years
  • participants should understand German or English
  • patients with a bionic hand are selected who are able to open and close the hand prosthesis.

Exclusion Criteria:

  • the standard contraindications for MRI will be checked for according to hospital protocol (ferromagnetic devices such as clips, claustrophobia, etc.) and, if necessary, patients will be excluded from participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients - bionic hand acquired
3 adult patients who acquired a bionic hand at the Medical University of Vienna after a traumatic brachial plexus lesion.
Diagnostic test: MRI
MRI scan
Other Names:
  • fMRI
  • functional MRI
Patients - bionic hand not yet acquired
3 patients eligible for the bionic hand prior to a possible amputation.
Diagnostic test: MRI
MRI scan
Other Names:
  • fMRI
  • functional MRI
Control subjects
Ten control subjects will be included for comparison.
Diagnostic test: MRI
MRI scan
Other Names:
  • fMRI
  • functional MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
task-related cortical activity - fMRI BOLD signal
Time Frame: MRI task scanning approximately 20 minutes
The investigators will measure cortical activity measured as a fMRI BOLD (blood-oxygen-level-dependent) signal, during four tasks: closing the hand (lef tand right) and motor imagery of this movement.
MRI task scanning approximately 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting state activity - fMRI BOLD signal
Time Frame: MRI resting state scanning approximately 10 minutes
The investigators will measure brain activity measured as a fMRI BOLD signal (blood-oxygen-level-dependent) during rest.
MRI resting state scanning approximately 10 minutes
diffusion tensor imaging (DTI) MRI
Time Frame: DTI scanning approximately 10 minutes
The investigators will measure mean diffusivity of the brain with DTI.
DTI scanning approximately 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Oskar Aszmann, prof. dr., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1955/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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