Grasp-Release Assessment of a Networked Neuroprosthesis Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorMetroHealth Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age > 16 years.
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);
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Networked Neuroprosthesis Device
DeviceThe 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.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Experimental: Intervention - implant neuroprosthesisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Grasp-Release Test
Ability to pick up, move, and release six standard objects
Time frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implantSecondary outcomes
1
Change in Grasp Dynameter(force)
Measure of muscular strength or the maximum force/tension generated by one's forearm muscles.
Time frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant2
Change in Canadian Occupational Performance Measure (COPM)
Evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time
Time frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant3
Change in Activities of Daily Living (ADL) Abilities Test
The Activities of Daily Living (ADL) profile uses both observation and interview to assess function in tasks completed in the personal, home, and community environments.
Time frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant4
Change in Spinal Cord Independence Measure III (SCIM-III)
The measure address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors)
Time frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
MetroHealth Medical Center
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov