This study is to evaluate the use of a fully implanted device for providing hand function, reach, and trunk function to individuals with cervical spinal cord injury.
Funding Sources:
FDA OOPD NIH NINDS
Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury
Biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test
Peripheral nerve innervation to upper extremity and trunk muscles, including a grade 3/5 or higher stimulated strength (Manual Muscle Test) in at least two of the following muscles in one arm: adductor pollicis, abductor pollicis brevis, flexor pollicis longus, extensor pollicis longus, extensor digitorum communis, flexor digitorum superficialis, flexor digitorum profundus, pronator quadratus, extensor carpi ulnaris, extensor carpi radialis brevis, extensor radialis longus, flexor carpi ulnaris, flexor carpi radialis, first dorsal interosseous; and in at least two of the following muscles: left/right gluteus maximus, left/right erector spinae, left/right quadratus lumborum,
Age > 16 years
Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant)
Other neurological conditions (multiple sclerosis, diabetes with peripheral nerve involvement)
History of coagulopathy, HIV, severe cardiopulmonary disease, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary disease.
Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia
Anne Bryden
Lead sponsor
MetroHealth Medical Center
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Case Western Reserve University
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
FDA Orphan Products Division
Collaborator