Clinical trial NCT04649749: Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury
Official title: Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Neuropathies
Traumatic Brachial Plexus Lesion
Bionic Hand Reconstruction
Keywords: traumatic brachial plexus lesion
bionic hand reconstruction
hand amputation
hand prosthesis
central programming
fMRI
resting state networks
DTI
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: task-related cortical activity - fMRI BOLD signal
timeFrame: MRI task scanning approximately 20 minutes
Secondary outcomes:
measure: resting state activity - fMRI BOLD signal
timeFrame: MRI resting state scanning approximately 10 minutes
measure: diffusion tensor imaging (DTI) MRI
timeFrame: DTI scanning approximately 10 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Oskar Aszmann, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aszmann OC, Roche AD, Salminger S, Paternostro-Sluga T, Herceg M, Sturma A, Hofer C, Farina D. Bionic reconstruction to restore hand function after brachial plexus injury: a case series of three patients. Lancet. 2015 May 30;385(9983):2183-9. doi: 10.1016/S0140-6736(14)61776-1. Epub 2015 Feb 25.
citation: Sturma A, Hruby LA, Prahm C, Mayer JA, Aszmann OC. Rehabilitation of Upper Extremity Nerve Injuries Using Surface EMG Biofeedback: Protocols for Clinical Application. Front Neurosci. 2018 Dec 4;12:906. doi: 10.3389/fnins.2018.00906. eCollection 2018.
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citation: Hotz-Boendermaker S, Funk M, Summers P, Brugger P, Hepp-Reymond MC, Curt A, Kollias SS. Preservation of motor programs in paraplegics as demonstrated by attempted and imagined foot movements. Neuroimage. 2008 Jan 1;39(1):383-94. doi: 10.1016/j.neuroimage.2007.07.065. Epub 2007 Aug 23.
citation: Date S, Kurumadani H, Yoshimura M, Fukae A, Onishi K, Hayashi J, Shinomiya R, Sunagawa T. Long-term disuse of the hand affects motor imagery ability in patients with complete brachial plexus palsy. Neuroreport. 2019 Apr 10;30(6):452-456. doi: 10.1097/WNR.0000000000001229.
citation: Anguelova GV, Rombouts SARB, van Dijk JG, Buur PF, Malessy MJA. Increased brain activation during motor imagery suggests central abnormality in Neonatal Brachial Plexus Palsy. Neurosci Res. 2017 Oct;123:19-26. doi: 10.1016/j.neures.2017.05.001. Epub 2017 May 4.