Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury (NCT02329652) | Clinical Trial Compass
RecruitingNot Applicable
Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
United States30 participantsStarted 2014-12-01
Plain-language summary
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
Who can participate
Age range17 Years
SexALL
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Inclusion Criteria:
* 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
* Medically stable - cleared for surgery
* Able and willing to take part in study
Exclusion Criteria:
* 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 dysreflex…