Grasp-Release Assessment of a Networked Neuroprosthesis Device
MetroHealth Medical Center
Summary
The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI.
Description
The Networked Neuroprosthesis(NNP) is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals. The NNP-UE Configuration activates nerves of the upper extremity (arm and hand), and senses voluntary motion and/or electromyogram (EMG) in order to provide hand grasp. The proposed work is focused on restoration of hand and reaching functions for people with cervical level spinal cord injury. For individuals who have sustained this…
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, age \> 16 years. * Cervical level spinal cord injury, as defined by: 1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and 2. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, or C; * Six months or more post-injury (neurostability); * Neurologically stable following any nerve transfers affecting the upper extremity (typically, one year post surgery); * Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity…
Interventions
- DeviceNetworked Neuroprosthesis Device
The Networked Neuroprosthesis Device is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals.
Location
- MetroHealth Medical CenterCleveland, Ohio