Grasp-Release Assessment of a Networked Neuroprosthesis Device

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, orC;

• 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 affectingthe upper extremity (typically, 6-months).

• Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 orhigher Stimulated Manual Muscle Test (SMMT) strength in at least two of thefollowing muscles in one arm:

1. Adductor Pollicus, Abductor Pollicus Brevis (AbPB), Flexor Pollicus Longus (FPL), Extensor Pollicus Longus (EPL)/Extensor Pollicus Brevis (EPB), ExtensorDigitorum Communis (EDC), Flexor Digitorum Superficialis (FDS), FlexorDigitorum Profundus (FDP), Pronator Quadratus (PQ), Extensor Carpi Ulnaris (ECU), Extensor Carpi Radialis Brevis (ECRB), Extensor Carpi Radialis Longus (ECRL), Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), First DorsalInterosseous(1DI), triceps,

2. At least two of the grade 3/5 or higher excitable muscles must also have grade 2/5 or lower voluntary strength;

• Good proximal upper extremity strength as defined bybiceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test onthe side intended for implantation;

• Medically stable;

• Able to understand and provide informed consent.

Exclusion Criteria:

• Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheralnerve involvement); Associated peripheral nerve / brachial plexus injury

• Progressive SCI;

• Co-existing cervical spine pathology (syrinx, unstable segment)

• Active implantable medical device (AIMD) such as a pacemaker or defibrillator;

• Active untreated infection such as pressure injury, urinary tract infection,pneumonia;

• History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorlycontrolled autonomic dysreflexia, or chronic obstructive pulmonary disease thatwould preclude safe participation in the trial as determined by the investigator;

• Unhealed fractures that prevent functional use of arm;

• Extensive upper extremity denervation (fewer than two excitable hand muscles);

• Involvement in other ongoing clinical studies that exclude concurrent involvement inthis study;

• Disorder or condition that requires MRI monitoring;

• Mechanical ventilator dependency;

• Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant);

• Presence of disease that might interfere with participant safety, compliance, orevaluation of the condition under study;

• Other significant medical findings that, in the opinion of the investigator,preclude safe participation in the trial.