Clinical trial NCT05863754: Grasp-Release Assessment of a Networked Neuroprosthesis Device
Official title: Grasp-Release Assessment of a Networked Neuroprosthesis Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury at C5-C7 Level
Spinal Cord Injuries
Spinal Cord Injury Cervical
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Case Western Reserve University
First posted: 2023-05-18
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The Networked Neuroprosthesis(NNP) 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. The NNP-UE Configuration activates nerves of the upper extremity (arm and hand), and senses voluntary motion and/or electromyogram (EMG) in order to provide hand grasp.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Grasp-Release Test
timeFrame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Secondary outcomes:
measure: Change in Grasp Dynameter(force)
timeFrame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
measure: Change in Activities of Daily Living (ADL) Abilities Test
timeFrame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
measure: Change in Spinal Cord Independence Measure III (SCIM-III)
timeFrame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Anne Bryden, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.