Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia
TETRAMINF
Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.
1 other identifier
interventional
21
1 country
2
Brief Summary
Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback. The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedSeptember 29, 2023
September 1, 2023
7.2 years
April 25, 2017
September 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wrist extension angle in degree during grasping with 3D motion analysis system
Individuals with C6-C7 tetraplegia extend their wrist to grasp using tenodesis. Specifically, the wrist extension shortens the tendons of fingers and thumbs flexors that elicit either a palmar or a lateral grip. A complete reach-to-grasp movement will be recorded using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Wrist extension angle in degree will be measure during grasping when the object is grasped.
Up to 19 weeks
Secondary Outcomes (13)
Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
Up to 19 weeks
Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
Up to 19 weeks
Brain activity change in response to intervention using magnetoencephalography
Up to 19 weeks
passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer
Up to 19 weeks
Upper limb strength measured using the hand held dynamometer
Up to 19 weeks
- +8 more secondary outcomes
Study Arms (3)
Motor imagery combined with neurofeedback (MINF)
EXPERIMENTALMotor imagery (MI)
ACTIVE COMPARATORControl (C)
SHAM COMPARATORInterventions
7 individuals with C6-C7 tetraplegia randomize in the experimental group consisting in motor imagery practice combined with visual neurofeedback (NF - i.e. performance of the imagined movement). Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. After each imagined movement, the NF based on brain activity measured by electroencephalography is display on a screen.
7 individuals with C6-C7 tetraplegia randomized in the active comparator group consisting in motor imagery practice alone without visual NF. This means that the performance of the imagined movement is not displayed to the participants. Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions.
7 individuals with C6-C7 tetraplegia randomized in the sham comparator group consisting in imagining geometric shapes by visualization. Shapes are successively displayed on a screen. Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions.
Eligibility Criteria
You may qualify if:
- Volunteer individuals with C6-C7 tetraplegia with complete finger flexor paralysis restricting grasping capabilities to the tenodesis.
- Consent to participate to the study after receiving clear, loyal and appropriate information.
- Aged between 18 and 55 years.
- Time since spinal cord injury above 6 months
- Stabilized condition in particular sensori-motor deficit.
- Sitting position for more than 1 hour
- Able to imagine movement
- Health care beneficiary
You may not qualify if:
- Long-lasting autonomic disorders while sitting (orthostatic hypotension and/or blood pressure instability) limiting sitting position to less than 1 hour.
- Upper limb pain for either mechanic or neuropathic reasons preventing all grasping movement and/or the ability to imagine those movements.
- Restricted wrist and finger range of motion preventing the tenodesis grasp.
- Patient after surgical tendon transfer that improved grasping capabilities (e.g. active finger flexion).
- Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias.
- Specific contraindication to Magnetoencephalography with the presence of metallic fragments inside the body such as pace-maker, neurostimulator, cochlear implants, steel dental implant and osteosynthesis material only applicable to the participants included in Lyon hospital center (n=15).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine
Montpellier, 34090, France
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230, France
Related Publications (2)
Mateo S, Di Rienzo F, Reilly KT, Revol P, Delpuech C, Daligault S, Guillot A, Jacquin-Courtois S, Luaute J, Rossetti Y, Collet C, Rode G. Improvement of grasping after motor imagery in C6-C7 tetraplegia: A kinematic and MEG pilot study. Restor Neurol Neurosci. 2015;33(4):543-55. doi: 10.3233/RNN-140466.
PMID: 26409412BACKGROUNDCharbonnier G, Reilly KT, Schwartz D, Daligault S, Luaute J, Rossetti Y, Collet C, Gelis A, Rode G, Mateo S. Grasping rehabilitation using motor imagery with or without neurofeedback after tetraplegia: a study protocol for a bicentric randomised controlled trial. BMJ Open. 2024 Oct 21;14(10):e074652. doi: 10.1136/bmjopen-2023-074652.
PMID: 39433413DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien MATEO, PhD
Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2017
First Posted
June 19, 2017
Study Start
March 29, 2018
Primary Completion
May 29, 2025
Study Completion
May 29, 2025
Last Updated
September 29, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Immediately following publication and ending 5 years following article publication.
- Access Criteria
- Proposals should be directed to sebastien.mateo@chu-lyon.fr. To gain access, data requestors will need to sign a data access agreement.
Individual participant data will be shared after deidentification (but only the data required for the new analysis will be transmitted). This includes for each visit and each participant averaged data of wrist extension angle during grasping of a single upper limb measured in degree with 3D motion analysis system. This includes for each visit, each participant and each upper limb: * Box and Block test * Nine Hole Peg test * hand held dynamometer for each of 4 muscles This includes for each visit and each participant the total score of: * manual muscle testing of the upper limb key muscles as defined by the ASIA score for each arm * Capability of Upper Limb * WHOQOL-Bref * Quadriplegic Index of Function * Kinesthetic Visual Imagery Questionnaire This also includes for each visit and each participant the passive range of motion expressed in degree and measured using goniometer for shoulder, elbow and wrist. This do not include electrophysiological measurements.