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

Brachial Plexus Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649749
• Other study ID #: 1955/2020
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• MRI
MRI scan

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	resting state activity - fMRI BOLD signal	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
Secondary	diffusion tensor imaging (DTI) MRI	The investigators will measure mean diffusivity of the brain with DTI.	DTI scanning approximately 10 minutes