Individuals With C6-C7 Tetraplegia (AIS A or B)TETRAMINFNCT03190863
Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia
A study testing Motor imagery combined with neurofeedback (MINF) and Motor imagery (MI) in people with Individuals With C6-C7 Tetraplegia (AIS A or B), run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Individuals With C6-C7 Tetraplegia (AIS A or B)
- What is being tested?
- Motor imagery combined with neurofeedback (MINF) and Motor imagery (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Mar 2018to 29 May 2025
- Phase
- Interventional
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine
Montpellier, 34090
Anthony GELIS, MD, a.gelis@propara.fr
Anthony GELIS, MD
- Recruiting
Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Sébastien MATEO, ext-sebastien.mateo@chu-lyon.fr
Gilles RODE, MD
About this study
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.
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.
- Being tested
- Motor imagery combined with neurofeedback (MINF), Motor imagery (MI), Control (C)
- Keywords
- Tenodesis grasp, Neurofeedback, Motor imagery, Reach-to-grasp, Rehabilitation, Physical therapy, Cervical spinal cord injury, Tetraplegia, AIS A, AIS B
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery combined with neurofeedback (MINF)Behavioural
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.
Motor imagery (MI)Behavioural
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.
Control (C)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery combined with neurofeedback (MINF) | Experimental | Not described Receives: Behavioral: Motor imagery combined with neurofeedback (MINF) |
| Motor imagery (MI) | Active comparator | Not described Receives: Behavioral: Motor imagery (MI) |
| Control (C) | Sham comparator | Not described Receives: Behavioral: Control (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start29 Mar 2018
- Primary completion29 May 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Individuals With C6-C7 Tetraplegia (AIS A or B)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien MATEO, PhD, Principal investigator, Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190863
- Sponsor's protocol ID
- 69HCL17_0016
- Acronym
- TETRAMINF
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 26409412Charbonnier 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.
PubMed 39433413
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03190863
- Acronym / sponsor ID
- TETRAMINF / 69HCL17_0016
- Keywords
- Tenodesis grasp, Neurofeedback, Motor imagery, Reach-to-grasp, Rehabilitation, Physical therapy, Cervical spinal cord injury, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 29 May 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 19 Jun 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor imagery combined with neurofeedback (MINF) | Experimental | Behavioral: Motor imagery combined with neurofeedback (MINF) |
| Motor imagery (MI) | Active comparator | Behavioral: Motor imagery (MI) |
| Control (C) | Sham comparator | Behavioral: Control (C) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | Motor imagery combined with neurofeedback (MINF) |
| 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. | Behavioural | Motor imagery (MI) |
| 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. | Behavioural | Control (C) |
Primary outcome
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.
13 secondary outcomes
Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
Time frame: Up to 19 weeks
Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).
Time frame: Up to 19 weeks
Brain activity change in response to intervention using magnetoencephalography
Time frame: Up to 19 weeks
passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer
Time frame: Up to 19 weeks
Upper limb strength measured using the hand held dynamometer
Time frame: Up to 19 weeks
Upper limb strength measured using the manual muscle test
Time frame: Up to 19 weeks
Hand dexterity measured using the Box and Block test
Time frame: Up to 19 weeks
Hand dexterity measured using the Nine Hole Peg test
Time frame: Up to 19 weeks
Hand dexterity measured using the Jebsen test
Time frame: Up to 19 weeks
Hand dexterity measured using the Capability of Upper Limb test
Time frame: Up to 19 weeks
Quality of Life measured using the WHOQOL-Bref
Time frame: Up to 19 weeks
Daily life autonomy measured using the Quadriplegic Index of Function
Time frame: Up to 19 weeks
Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire
Time frame: Up to 19 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 26409412Mateo 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.
- Derived from this study: PubMed 39433413Charbonnier 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.
- Individual participant dataSharing planned: Yes. 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.
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.
Sébastien MATEO, PhD principal investigator
Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery combined with neurofeedback (MINF) and Motor imagery (MI) in people with Individuals With C6-C7 Tetraplegia (AIS A or B), run by Hospices Civils de Lyon at 2 sites in France.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 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 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien MATEO, PhD (478 865 066 ext. +33, sebastien.mateo@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist extension angle in degree during grasping with 3D motion analysis system (time frame: Up to 19 weeks). 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 NCT03190863, which also lists 2 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 29 Sep 2023.