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Neuroprosthetic System for Spinal Cord Injury

This study is testing a fully implanted device called the Networked Neuroprosthetic System for Grasp and Trunk. It aims to help people with spinal cord injuries at the C5-C7 level regain hand function, reach, and trunk control. Researchers want to see if this system can improve daily activities three months after the device is implanted. You might be able to join if you are 17 or older, have a cervical spinal cord injury (C4-C8 motor level, AIS grade A, B, C, or D), and it's been at least six months since your injury. You also need to have certain arm muscle strength (biceps/brachialis/brachioradialis strength of 2/5 or higher). The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional study involving 30 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive an implanted networked neuroprosthesis.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring activities of daily living is at three months post-implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02329652

Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury

Recruiting
NAAges 17+InterventionalTreatment
Anne Bryden
~30 participants
Updated 2025-12-19 on ClinicalTrials.gov
What's tested:Networked Neuroprosthetic System for Grasp and Trunk

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Activities of Daily Living Abilities Test
Measured over Three months post-implant

Conditions

Spinal Cord Injuries
Spinal Cord Injury at C5-C7 Level
Spinal Cord Injury Cervical
Spinal Cord Injury at C5-C7 Level With Complete Lesion
Spinal Cord Injury at C5-C7 Level With Incomplete Lesion

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Anne L Byrden, Ph.D.
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
Presence of other active implantable medical devices with unknown or untested interaction with the NNP implant
Active implantable medical device (AIMD) such as a pacemaker or defibrillator, with the exception of the implanted stimulator-telemeter (IST) or implanted receiver stimulator (IRS) systems developed by the Cleveland Functional Electrical Stimulation Center
Unhealed fractures that prevent functional use of arm or trunk
Less than six months post-injury (neuroprosthesis implantation delayed until criteria met)
Extensive upper extremity denervation (fewer than two stimulatable hand muscles and two stimulatable trunk muscles)
Involvement in other ongoing clinical studies that exclude concurrent until criteria met)
Disorder or condition that require MRI monitoring
Mechanical ventilator dependency
Progressive SCI In subjects who are undergoing bilateral implantation, subjects should not have a history of autonomic dysreflexia, hypertension, diabetes or any condition which requires frequent blood pressure monitoring or frequent venipuncture.
Adverse interaction between system components and typical electromagnetic (EM) sources in subject's home and work environments, including wheelchair or other active implantable devices.

What this trial measures

  • Activities of Daily Living Abilities TestThree months post-implant

    Evaluation of ability to perform activities of daily living when using the neuroprosthesis compared to ability when the neuroprosthesis is turned off.