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| Name | Class |
|---|---|
| Institut National de Recherche en Informatique et en Automatique | OTHER |
| NEURINNOV | UNKNOWN |
| Centre Bouffard Vercelli - USSAP | OTHER |
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A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median and radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery.
Our main hypothesis is that multipolar neural electrical stimulation of the median nerve (flexion) and the radial nerve (extension) allows:
Electrical stimulation of the muscles has been used for decades in rehabilitation units specializing in the treatment of spinal cord injuries. It has been shown to be effective in building muscle and preventing muscle atrophy following spinal cord injury (SCI) or stroke. It can also be used to reduce spasticity and above all to promote functionally useful motor control. It is then a Functional Electric Stimulation (FES). In the quadriplegic person marked by a severe motor deficiency of the upper limbs, FES is today the only technique allowing to restore a functional gripping movements in the case where the active muscular resources below the elbows are missing or too weak to allow tendon transfer surgery.
Like "Freehand", all the devices using FES directly stimulate the muscles (surface, intramuscular or epimysial electrodes) and therefore require a high number of internal components with a theoretical risk of infection and greater rejection. since each muscle must be activated via an electrode (up to 12 in the case of "FreeHand"). The investigators propose instead selective neural stimulation as it allows stimulating several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median and radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk thanks to minimally invasive surgery. The procedure consisted of placing a multi-contact cuff electrode around the radial or median nerves and observing the effects of electrical neural stimulation in terms of muscle selectivity, force produced and movement induced. In a previous study, the investigators already proved through acute intra operative testing (under Ethics Committee approval, #NCT03721861) that:
A second feasibility study (Ethics committee registration #2016-A00711-50) with 17 quadriplegic patients assessed the subject's ability to use voluntary contractions of sus lesional muscles (EMG recordings in 8 subjects) or voluntary movements of shoulders (inertial recordings in 9 subjects) to control the movements of a robotic hand or the triggering of an electrical surface stimulation of the muscles of the forearm. All of the patients managed to master the proposed interface after a short familiarization period.
On the basis of the results of these two studies, the investigator wish to take an additional step in the development of a gripping assistance device for patients with spinal cord injury:
- by proposing the implantation of two cuff electrodes with percutaneous connection on the arm of quadriplegic people. The electrodes will be kept in place for a period of 1 month before being definitively explanted. An implanted cable will connect the electrodes to an external connector.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurostimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulation | Device | Implantation of 2 multicontact cuff electrodes in the upper limb of patients with tetraplegia and control of the stimulation by contralateral shoulder movements |
| Measure | Description | Time Frame |
|---|---|---|
| Selectivity index of the configurations which allow an individualized recruitment of the different muscles at D+29 | Selectivity index of the configurations (active contacts of the electrode and stimulation parameters) which allow an individualized recruitment of the different muscles at D+29 based on the combination of the increase of the Root Mean Square (RMS) value of the Electromyography (EMG) and variation of 10% of the maximum distance covered by the considered segment compared with the rest position. | End of the protocole (day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Capacities Scale (MCS) | The Motor Capacity Scale (MCS) which studies the Key Grip and Grasp sockets in their 3 facets (catching, holding and letting go). MCS should be above 27. | Day 29 |
| Test n°1 of the 400 Points assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles FATTAL, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service MPR: USSAP Centre Bouffard-Vercelli, Pôle Santé du | Perpignan | 66962 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41535942 | Derived | Azevedo Coste C, Guiho T, Ferreira F, Bailly F, Degeorge B, Geffrier A, Andreu D, Teissier J, Guiraud D, Fattal C. Restoring hand grasping for patients with a complete tetraplegia with selective epineural stimulation: a parsimonious thus relevant clinical approach. J Neuroeng Rehabil. 2026 Jan 14;23(1):111. doi: 10.1186/s12984-025-01857-9. | |
| 36202865 |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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functional relevance of neural implantation via the production of 4 movements considered useful: an opening of the 5 fingers, a digito-palmar grip with thumb, a digito-palmar grip without thumb and an end-to-side thumb grip Test No. 1 of the 400 POINTS balance sheet, which brings together the study of 12 hand functions. POINTS score should be above 60.
| Day 29 |
| The rate in % of total tests of grasping objects. | Testing of two methods of autonomous control of the device by the patient. The successful rate in % of total tests of grasping objects. The success rate should be above 80%. | Day 29 |
| Optimal stimulation strategies obtained for a synergistic functional control | For each movement, the minimum stimulation intensity to produce the movement will be noted. In mA this intensity should be as low as possible. A value above 1.5 mA of failure to obtain the desired movement will be considered as a failed outcome. | Day 29 |
| The impedance of the electrode contacts. | Assessment of the evolution of the quality of the stimulation over time (stability of the settings and of the tissue / electrode interface). A Impedance of the electrode contacts to assess the state of the contact between the electrode poles and the nerve tissue. The state of contact between the electrode poles and the nervous tissue will be evaluated by measuring the impedance of the electrode contacts. This impedance expressed in k ohms, should not be higher than 5. Above this threshold the contact will be considered to be non-functional. For each movement, the minimum stimulation intensity (in mA) to initiate the movement should stay below 1.5 mA. | Day 29 |
| Local skin tolerance | Local skin tolerance assessed by the number of patients with dermatological lesions at the implantation site, of allergic and/or infectious type during the month following implantation. The answer provided daily will be binary yes / no. | Day 29 |
| Local algological tolerance (1) | Local algological tolerance assessed by number of patients with at least one pain at the implant site, qualified as neuropathic or nociceptive and quantified as > or = 3/10 using a digital analog scale from 0 to 10, during the month following implantation. | Day 29 |
| Local algological tolerance (2) | Local algological tolerance assessed by average intensity of daily pain | Day 29 |
| Coste CA, William L, Fonseca L, Hiairrassary A, Andreu D, Geffrier A, Teissier J, Fattal C, Guiraud D. Activating effective functional hand movements in individuals with complete tetraplegia through neural stimulation. Sci Rep. 2022 Oct 6;12(1):16189. doi: 10.1038/s41598-022-19906-x. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |