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

NCT02329652 | Recruiting DMC FDA Device

• 5 other identifiers: NNP-UE+TU01NS069517UH2NS103863OPD #5409CDMRP-SC090230
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Activities of Daily Living Abilities Test

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

  Three months post-implant

Secondary Outcomes (1)

• Grasp-Release Test

  Pre-implant and three months post-implant

Study Arms (1)

Intervention - implant neuroprosthesis

EXPERIMENTAL

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

Device: Networked Neuroprosthetic System for Grasp and Trunk

Interventions

Networked Neuroprosthetic System for Grasp and Trunk DEVICE

Receive implanted networked neuroprosthesis

Intervention - implant neuroprosthesis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anne Bryden: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Case Western Reserve University: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• FDA Orphan Products Division: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Related Publications (4)

• 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

• Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.

  PMID: 18406958 RESULT

Related Links

• Cleveland Functional Electrical Stimulation Center

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 19, 2025

Record last verified: 2025-10

Locations

US (1)