Rehabilitation for grasping using motor imagery and neurofeedback after tetraplegia
Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.
This study is testing if combining brain training with feedback can help people with C6-C7 tetraplegia improve their ability to grasp objects better than just using brain training alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT03190863 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of motor imagery combined with neurofeedback in improving grasping capabilities in individuals with C6-C7 tetraplegia. Participants will be randomly assigned to receive either motor imagery with neurofeedback, motor imagery alone, or a control intervention. The study aims to determine if neurofeedback, which provides visual information about brain activity during covert practice, enhances the rehabilitation process compared to motor imagery alone. The trial is multicentric and seeks to provide higher-level evidence for this innovative rehabilitation approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 55 with C6-C7 tetraplegia and complete finger flexor paralysis who can imagine movement.
Not a fit: Patients with upper limb pain, restricted wrist and finger motion, or those who have undergone surgical tendon transfer that improved grasping capabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve grasping abilities in individuals with tetraplegia, enhancing their independence and quality of life.
How similar studies have performed: While the use of motor imagery in rehabilitation has shown promise, the combination with neurofeedback in this specific context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Montpellier and 1 other locations
- Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine — Montpellier, France (Recruiting)
- Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle — Saint-Genis-Laval, France (Recruiting)
Study contacts
- Principal investigator: Sébastien MATEO, PhD — Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.
- Study coordinator: Sébastien MATEO, PhD
- Email: sebastien.mateo@chu-lyon.fr
- Phone: 478 865 066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.