Recruiting

Neuroprosthetic System

Sponsor:

Anne Bryden

Code:

NCT02329652

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

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

Networked Neuroprosthetic System for Grasp and Trunk

Study Details

Brief 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

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

Study ID

NCT02329652

Start date

Dec 1, 2014

Status verified date

Oct, 2025

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention - implant neuroprosthesis

Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.

Interventions

Networked Neuroprosthetic System for Grasp and Trunk

Receive implanted networked neuroprosthesis

Primary outcome measure

  • Activities of Daily Living Abilities Test [ Time Frame: Three months post-implant ]

Central Contacts and Locations

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Anne L Byrden, Ph.D.

UE.FES.ClinicalTrials@gmail.com

Principal Investigator:

Anne L Bryden, Ph.D.

More Information

Sponsor

Anne Bryden

Last update posted

Dec 19, 2025

Last verified

Oct, 2025

Keywords

  • Neuroprosthesis
  • Functional Electrical Stimulation
  • Grasp
  • Posture
  • Standing
  • Function
  • Recovery
  • Device
  • Stimulation
  • Implant
  • Reach
  • Independence
  • Activities of Daily Living

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anne Bryden on 2025-12-19.