Grasp-Release Assessment of a Networked Neuroprosthesis Device

NCT05863754 | Recruiting DMC FDA Device

• 1 other identifier: IRB20-00854
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Grasp-Release Test

  Ability to pick up, move, and release six standard objects

  Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

Secondary Outcomes (4)

• Change in Grasp Dynameter(force)

  Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

• Change in Canadian Occupational Performance Measure (COPM)

  Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

• Change in Activities of Daily Living (ADL) Abilities Test

  Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

• Change in Spinal Cord Independence Measure III (SCIM-III)

  Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

Study Arms (1)

Experimental: Intervention - implant neuroprosthesis

EXPERIMENTAL

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

Device: Networked Neuroprosthesis Device

Interventions

Networked Neuroprosthesis Device 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.

Experimental: Intervention - implant neuroprosthesis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age \> 16 years.
• Cervical level spinal cord injury, as defined by:
• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and
• 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:
• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Related Publications (3)

• Ho CH, Triolo RJ, Elias AL, Kilgore KL, DiMarco AF, Bogie K, Vette AH, Audu ML, Kobetic R, Chang SR, Chan KM, Dukelow S, Bourbeau DJ, Brose SW, Gustafson KJ, Kiss ZH, Mushahwar VK. Functional electrical stimulation and spinal cord injury. Phys Med Rehabil Clin N Am. 2014 Aug;25(3):631-54, ix. doi: 10.1016/j.pmr.2014.05.001.

  PMID: 25064792 BACKGROUND

• Peckham PH, Kilgore KL. Challenges and opportunities in restoring function after paralysis. IEEE Trans Biomed Eng. 2013 Mar;60(3):602-9. doi: 10.1109/TBME.2013.2245128. Epub 2013 Mar 7.

  PMID: 23481680 BACKGROUND

• Makowski N, Campean A, Lambrecht J, Buckett J, Coburn J, Hart R, Miller M, Montague F, Crish T, Fu M, Kilgore K, Peckham PH, Smith B. Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. IEEE Trans Biomed Circuits Syst. 2021 Apr;15(2):281-293. doi: 10.1109/TBCAS.2021.3066838. Epub 2021 May 25.

  PMID: 33729949 BACKGROUND

Related Links

• Cleveland Functional Electrical Stimulation Center

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Anne Bryden, PhD, OTR/L

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KIm Walsh, OTR/L

CONTACT

216-957-3512; kwalsh3@metrohealth.org

Anne Bryden, Ph.D, OTR/L

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: January 23, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)