Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration.

Two multi-contact epineural electrodes were placed around radial and median nerves of two subjects with high tetraplegia C4, American Spinal Injury Association Impairment Scale (AIS) A, group 0 of the International Classification for Surgery of the Hand in Tetraplegia. The purpose was to study the safety and capability of these electrodes to generate synergistic motor activation and functional movements and to test control interfaces that allow subjects to trigger pre-programmed stimulation sequences. The device consists of a pair of neural cuff electrodes and percutaneous cables with two extracorporeal connection cables inserted during a surgical procedure and maintained for 28 days. Continuity tests of the electrodes, selectivity of movements induced, motor capacities for grasping and gripping, conformity of the control order, tolerance, and acceptability were assessed. Neither of the two participants showed general and local comorbidity. Acceptability was optimal. None of the stimulation configurations generated contradictory movements. The success rate in task execution by the electro-stimulated hand exceeded the target of 50% (54% and 51% for patients 1 and 2, respectively). The compliance rate of the control orders in both patients was >90% using motion inertial measurement unit (IMU)-based detection and 100% using electromyography (EMG)-based detection in patient 1. These results support the relevance of neural stimulation of the tetraplegic upper limb with a more selective approach, using multi-contact epineural electrodes with nine and six contact points for the median and radial nerve respectively.