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

NCT04649749 | Completed

• 1 other identifier: 1955/2020
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• task-related cortical activity - fMRI BOLD signal

  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 Outcomes (2)

• resting state activity - fMRI BOLD signal

  MRI resting state scanning approximately 10 minutes

• diffusion tensor imaging (DTI) MRI

  DTI scanning approximately 10 minutes

Study Arms (3)

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

Patients - bionic hand not yet acquired

3 patients eligible for the bionic hand prior to a possible amputation.

Diagnostic Test: MRI

Control subjects

Ten control subjects will be included for comparison.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

MRI scan

Also known as: functional MRI, fMRI

Control subjects; Patients - bionic hand acquired; Patients - bionic hand not yet acquired

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Related Publications (7)

• 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.

  PMID: 25724529 BACKGROUND

• 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.

  PMID: 30564090 BACKGROUND

• Decety J, Grezes J. Neural mechanisms subserving the perception of human actions. Trends Cogn Sci. 1999 May;3(5):172-178. doi: 10.1016/s1364-6613(99)01312-1.

  PMID: 10322473 BACKGROUND

• Lotze M, Flor H, Grodd W, Larbig W, Birbaumer N. Phantom movements and pain. An fMRI study in upper limb amputees. Brain. 2001 Nov;124(Pt 11):2268-77. doi: 10.1093/brain/124.11.2268.

  PMID: 11673327 BACKGROUND

• 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.

  PMID: 17919932 BACKGROUND

• 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.

  PMID: 30855560 BACKGROUND

• 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.

  PMID: 28479130 BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Oskar Aszmann, prof. dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Researcher at Medical University of Vienna, Austria

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: December 2, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

AU (1)