An Early Feasibility Study of the ReHAB System

The overall purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings. Device Name: Reconnecting the Hand and Arm to the Brain (ReHAB) System Intended Use The proposed device is intended to allow greater functional independence for individuals who are paralyzed due to disease or injury. The purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings. The target population are individuals with high tetraplegia, defined as less than antigravity weakness of both upper extremities and both lower extremities as a result of an identified and static (stable for at least 3 months) injury or disease affecting upper motor neurons process that prevents motor neural activity from activating muscles below the neck to perform functional activities. Injuries and diseases that lead to this clinical condition include spinal cord injury, and stroke. Objective(s): The primary objective of this study is to evaluate the safety, tolerability, and potential efficacy of an approach combining multiple intracortical brain recording/stimulating microarrays with direct peripheral nerve and muscle stimulation for restoration of arm and hand movement in people with high tetraplegia. Secondary objectives include validation of the combined platform described above as a clinical device to allow paralyzed individuals to have a more meaningful interaction with their environment as assessed by ability to perform brain-controlled reaching and grasping tasks that ultimately might allow for greater functional independence.