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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04649749
Enrollment
11
Registered
2020-12-02
Start date
2020-10-01
Completion date
2022-09-01
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bionic Hand Reconstruction, Brachial Plexus Neuropathies, Traumatic Brachial Plexus Lesion

Keywords

traumatic brachial plexus lesion, bionic hand reconstruction, hand amputation, hand prosthesis, central programming, fMRI, resting state networks, DTI

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.

Interventions

DIAGNOSTIC_TESTMRI

MRI scan

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
task-related cortical activity - fMRI BOLD signalMRI task scanning approximately 20 minutesThe 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.

Secondary

MeasureTime frameDescription
resting state activity - fMRI BOLD signalMRI resting state scanning approximately 10 minutesThe investigators will measure brain activity measured as a fMRI BOLD signal (blood-oxygen-level-dependent) during rest.
diffusion tensor imaging (DTI) MRIDTI scanning approximately 10 minutesThe investigators will measure mean diffusivity of the brain with DTI.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026