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Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia (TETRAMINF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190863
Recruitment Status : Unknown
Verified December 2020 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : June 19, 2017
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Individuals With C6-C7 Tetraplegia (AIS A or B) Behavioral: Motor imagery combined with neurofeedback (MINF) Behavioral: Motor imagery (MI) Behavioral: Control (C) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : May 29, 2023
Estimated Study Completion Date : May 29, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Wrist extension angle in degree during grasping with 3D motion analysis system [ Time Frame: Up to 19 weeks ]
    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.


Secondary Outcome Measures :
  1. Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK). [ Time Frame: Up to 19 weeks ]
    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.

  2. Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK). [ Time Frame: Up to 19 weeks ]
    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.

  3. Brain activity change in response to intervention using magnetoencephalography [ Time Frame: Up to 19 weeks ]
    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.

  4. passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer [ Time Frame: Up to 19 weeks ]
    This outcome will be measured using goniometer and/or inclinometer by the same blind and experienced physical therapist

  5. Upper limb strength measured using the hand held dynamometer [ Time Frame: Up to 19 weeks ]
    This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist.

  6. Upper limb strength measured using the manual muscle test [ Time Frame: Up to 19 weeks ]
    This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist.

  7. Hand dexterity measured using the Box and Block test [ Time Frame: Up to 19 weeks ]
    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

  8. Hand dexterity measured using the Nine Hole Peg test [ Time Frame: Up to 19 weeks ]
    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

  9. Hand dexterity measured using the Jebsen test [ Time Frame: Up to 19 weeks ]
    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

  10. Hand dexterity measured using the Capability of Upper Limb test [ Time Frame: Up to 19 weeks ]
    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

  11. Quality of Life measured using the WHOQOL-Bref [ Time Frame: Up to 19 weeks ]
    This outcome will be measured using the WHOQOL-Bref by the same blind and experienced physical therapist.

  12. Daily life autonomy measured using the Quadriplegic Index of Function [ Time Frame: Up to 19 weeks ]
    This outcome will be measured using the Quadriplegic Index of Function by the same blind and experienced physical therapist.

  13. Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire [ Time Frame: Up to 19 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190863


Contacts
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Contact: Sébastien MATEO, PhD 478 865 066 ext +33 sebastien.mateo@chu-lyon.fr
Contact: Gilles RODE, PhD 478 865 066 ext +33 gilles.rode@chu-lyon.fr

Locations
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France
Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine Recruiting
Montpellier, France, 34090
Contact: Anthony GELIS, MD       a.gelis@propara.fr   
Principal Investigator: Anthony GELIS, MD         
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle Recruiting
Saint-Genis-Laval, France, 69230
Contact: Sébastien MATEO       ext-sebastien.mateo@chu-lyon.fr   
Principal Investigator: Gilles RODE, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sébastien MATEO, PhD Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
More Information
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Additional Information:

Publications:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03190863    
Other Study ID Numbers: 69HCL17_0016
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Tenodesis grasp
Neurofeedback
Motor imagery
Reach-to-grasp
Rehabilitation
 Physical therapy
Cervical spinal cord injury
Tetraplegia
AIS A
AIS B
Additional relevant MeSH terms:
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Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases