Recruiting

NP-UE

Sponsor:

MetroHealth Medical Center

Code:

NCT05863754

Conditions

Spinal Cord Injury at C5-C7 Level

Spinal Cord Injuries

Spinal Cord Injury Cervical

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Networked Neuroprosthesis Device

Study Details

Brief summary:

The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI.

Conditions

Spinal Cord Injury at C5-C7 Level

Spinal Cord Injuries

Spinal Cord Injury Cervical

Study ID

NCT05863754

Start date

Jan 23, 2022

Status verified date

Aug, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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, or C;
  • 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 affecting the upper extremity (typically, 6-months).
  • Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 or higher Stimulated Manual Muscle Test (SMMT) strength in at least two of the following muscles in one arm:

1. Adductor Pollicus, Abductor Pollicus Brevis (AbPB), Flexor Pollicus Longus (FPL), Extensor Pollicus Longus (EPL)/Extensor Pollicus Brevis (EPB), Extensor Digitorum Communis (EDC), Flexor Digitorum Superficialis (FDS), Flexor Digitorum 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 Dorsal Interosseous(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 by biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test on the side intended for implantation;
  • Medically stable;
  • Able to understand and provide informed consent.

Exclusion Criteria:

  • Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve 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, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease that would 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 in this 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, or evaluation of the condition under study;
  • Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial.

Study Design

Enrollment

13 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Intervention - implant neuroprosthesis

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

Interventions

Networked Neuroprosthesis Device

The Networked Neuroprosthesis Device is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals.

Primary outcome measure

  • Change in Grasp-Release Test [ Time Frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant ]

Central Contacts and Locations

Central contacts

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Anne Bryden, Ph.D, OTR/L

216-957-3594anne.bryden@case.edu

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Dec 19, 2025

Last verified

Aug, 2025

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