Brachial Plexus NeuropathiesNCT04649749
Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury
An observational study of Brachial Plexus Neuropathies and Traumatic Brachial Plexus Lesion, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Neuropathies, Traumatic Brachial Plexus Lesion, Bionic Hand Reconstruction
- What is being tested?
- MRI
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- MRI
- Keywords
- traumatic brachial plexus lesion, bionic hand reconstruction, hand amputation, hand prosthesis, central programming, fMRI, resting state networks, DTI
- Medical subject headings
- Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called functional MRI, fMRI
MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Patients - bionic hand acquired | 3 adult patients who acquired a bionic hand at the Medical University of Vienna after a traumatic brachial plexus lesion. Receives: Diagnostic Test: MRI | |
| Patients - bionic hand not yet acquired | 3 patients eligible for the bionic hand prior to a possible amputation. Receives: Diagnostic Test: MRI | |
| Control subjects | Ten control subjects will be included for comparison. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MRI task scanning approximately 20 minutes
Secondary outcomes (2)
resting state activity - fMRI BOLD signal
The investigators will measure brain activity measured as a fMRI BOLD signal (blood-oxygen-level-dependent) during rest.
Measured: MRI resting state scanning approximately 10 minutes
diffusion tensor imaging (DTI) MRI
The investigators will measure mean diffusivity of the brain with DTI.
Measured: DTI scanning approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus NeuropathiesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galia Valentinova Anguelova, Medical University of Vienna
- Investigators
- Oskar Aszmann, prof. dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649749
- Sponsor's protocol ID
- 1955/2020
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25724529Sturma 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.
PubMed 30564090Decety 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.
PubMed 10322473Lotze 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.
PubMed 11673327Hotz-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.
PubMed 17919932Date 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.
PubMed 30855560Anguelova 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.
PubMed 28479130
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury
- ClinicalTrials.gov ID
- NCT04649749
- Acronym / sponsor ID
- 1955/2020
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients - bionic hand acquired | – | Diagnostic Test: MRI3 adult patients who acquired a bionic hand at the Medical University of Vienna after a traumatic brachial plexus lesion. |
| Patients - bionic hand not yet acquired | – | Diagnostic Test: MRI3 patients eligible for the bionic hand prior to a possible amputation. |
| Control subjects | – | Diagnostic Test: MRITen control subjects will be included for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: functional MRI, fMRIMRI scan | Diagnostic test | Control subjects, Patients - bionic hand acquired, Patients - bionic hand not yet acquired |
Primary outcome
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.
2 secondary outcomes
resting state activity - fMRI BOLD signal
Time frame: MRI resting state scanning approximately 10 minutes
diffusion tensor imaging (DTI) MRI
Time frame: DTI scanning approximately 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 25724529Aszmann 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.
- Background: PubMed 30564090Sturma 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.
- Background: PubMed 10322473Decety 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.
- Background: PubMed 11673327Lotze 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.
- Background: PubMed 17919932Hotz-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.
- Background: PubMed 30855560Date 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.
- Background: PubMed 28479130Anguelova 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oskar Aszmann, prof. dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Neuropathies and Traumatic Brachial Plexus Lesion, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
task-related cortical activity - fMRI BOLD signal (time frame: MRI task scanning approximately 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649749, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.