Grasp-Release Assessment of a Networked Neuroprosthesis Device
NCT ID: NCT05863754
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
13 participants
INTERVENTIONAL
2022-01-23
2028-12-01
Brief Summary
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Detailed Description
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The proposed work is focused on restoration of hand and reaching functions for people with cervical level spinal cord injury. For individuals who have sustained this injury, restoration of hand function is their top priority, and existing alternatives are limited. Neuroprosthesis are the most promising method for significant gain in hand and arm function.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: Intervention - implant neuroprosthesis
Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
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Anne Bryden
Principal Investigator
Principal Investigators
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Anne Bryden, PhD, OTR/L
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Anne Bryden, Ph.D, OTR/L
Role: primary
References
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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.
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.
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.
Related Links
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Cleveland Functional Electrical Stimulation Center
Other Identifiers
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IRB20-00854
Identifier Type: -
Identifier Source: org_study_id