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.

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.

Study Overview

• Status: Recruiting
• Conditions: Individuals With C6-C7 Tetraplegia (AIS A or B)
• Intervention / Treatment: Behavioral: Motor imagery combined with neurofeedback (MINF); Behavioral: Motor imagery (MI); Behavioral: Control (C)

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien MATEO, PhD; Phone Number: +33 478 865 066; Email: sebastien.mateo@chu-lyon.fr
• Study Contact Backup: Name: Gilles RODE, PhD; Phone Number: +33 478 865 066; Email: gilles.rode@chu-lyon.fr

Study Locations

• France
  • Montpellier, France, 34090
    • Recruiting
    • Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine
    • Contact: Anthony GELIS, MD; Email: a.gelis@propara.fr
    • Principal Investigator: Anthony GELIS, MD
  • Saint-Genis-Laval, France, 69230
    • Recruiting
    • Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle
    • Contact: Sébastien MATEO; Email: ext-sebastien.mateo@chu-lyon.fr
    • Principal Investigator: Gilles RODE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor imagery combined with neurofeedback (MINF)	Behavioral: Motor imagery combined with neurofeedback (MINF); 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.
Active Comparator: Motor imagery (MI)	Behavioral: Motor imagery (MI); 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.
Sham Comparator: Control (C)	Behavioral: Control (C); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).	Computation of temporal kinematic parameters (e.g. movement duration) measured during a complete reach-to-grasp movement using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Temporal parameters are also aggregated with spatial parameters.	Up to 19 weeks
Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).	Computation of spatial kinematic parameters (e.g. movement trajectory) measured during a complete reach-to-grasp movement using a 3D motion analysis system (Vicon Motion Systems Ltd. UK).Spatial parameters are also aggregated with temporal parameters.	Up to 19 weeks
Brain activity change in response to intervention using magnetoencephalography	Brain activity will be measured during upper limb movement (e.g. a complete reach-to-grasp movement) using magnetoencephalography. The device is only available in Lyon Hospital. Correspondingly, fifteen participants included in Lyon Hospital will achieve this measure.	Up to 19 weeks
passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer	This outcome will be measured using goniometer and/or inclinometer by the same blind and experienced physical therapist	Up to 19 weeks
Upper limb strength measured using the hand held dynamometer	This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist.	Up to 19 weeks
Upper limb strength measured using the manual muscle test	This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist.	Up to 19 weeks
Hand dexterity measured using the Box and Block test	This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist	Up to 19 weeks
Hand dexterity measured using the Nine Hole Peg test	This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist	Up to 19 weeks
Hand dexterity measured using the Jebsen test	This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist	Up to 19 weeks
Hand dexterity measured using the Capability of Upper Limb test	This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist	Up to 19 weeks
Quality of Life measured using the WHOQOL-Bref	This outcome will be measured using the WHOQOL-Bref by the same blind and experienced physical therapist.	Up to 19 weeks
Daily life autonomy measured using the Quadriplegic Index of Function	This outcome will be measured using the Quadriplegic Index of Function by the same blind and experienced physical therapist.	Up to 19 weeks
Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire	Motor imagery capability will be measured by the Kinesthetic Visual Imagery Questionnaire by the same blind and experienced physical therapist along with comparing overt and covert movement duration, galvanic skin response, electroencephalography activity.	Up to 19 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sébastien MATEO, PhD, Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Estimated): May 29, 2025
• Study Completion (Estimated): May 29, 2025

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy; Neurofeedback; Tetraplegia; Motor imagery; Tenodesis grasp; Reach-to-grasp; Cervical spinal cord injury; AIS A; AIS B
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Quadriplegia
• Other Study ID Numbers: 69HCL17_0016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Immediately following publication and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No