Neuroprosthesis Device for Spinal Cord Injury
(GRANND Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: MetroHealth Medical Center
Disqualifiers: MS, Diabetes, Cervical spine pathology, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing an implantable device called NP-UE that helps people with cervical spinal cord injuries move their arms and hands. The device sends signals to nerves to make muscles move and senses attempts to move, helping restore hand function. The NP-UE device is part of a second-generation system that helps control hand grasp and elbow extension in individuals with cervical spinal cord injury.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.
What data supports the effectiveness of the treatment Networked Neuroprosthesis Device for spinal cord injury?
The Networked Neuroprosthesis (NNP) system has been successfully designed, manufactured, and tested, showing it can generate stimulus pulses and record important signals in people with spinal cord injury. Additionally, neuroprostheses that stimulate paralyzed muscles have been shown to restore functions like standing and grasping in individuals with spinal cord injuries, suggesting potential benefits of the NNP system.
12345Is the Neuroprosthesis Device for Spinal Cord Injury safe for humans?
The Neuroprosthesis Device, including its variations like the Networked Neuroprosthesis (NNP), has been tested in humans with spinal cord injuries and shown to be safe. Studies report no medical complications from the implanted components, and the devices have been used successfully for over 20 years, demonstrating their durability and safety.
14678How is the Networked Neuroprosthesis Device treatment different from other treatments for spinal cord injury?
The Networked Neuroprosthesis Device is unique because it is a fully implanted modular system that can stimulate and record signals from paralyzed muscles, allowing for more precise and coordinated muscle activation compared to traditional single-device neuroprostheses. This modular approach enables the restoration of multiple functions and offers a more integrated and potentially more effective solution for individuals with spinal cord injuries.
12357Eligibility Criteria
This trial is for individuals over 16 years old with a stable cervical spinal cord injury (SCI) at levels C1-C7 and AIS grades A, B, or C. They must have certain upper extremity muscle strength and be medically stable. Excluded are those with other neurological conditions, active infections, pregnancy, co-existing cervical spine issues, or involvement in conflicting studies.Inclusion Criteria
My spinal cord injury is in my neck and is classified as severe to moderate.
I had nerve surgery on my arm and have been stable for over a year.
My health condition is currently stable.
+6 more
Exclusion Criteria
I have a history of blood clotting disorders, HIV, heart/lung disease, slow heart rate, uncontrolled nerve system reactions, or COPD.
I have a neurological condition like MS or diabetes affecting my nerves.
Progressive SCI
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implantation and Initial Assessment
Participants receive the implanted networked neuroprosthetic system and undergo initial functional training and assessment
3 months
Multiple visits for implantation and initial assessments
Post-implant Follow-up
Participants are monitored for safety and effectiveness with assessments at 3, 6, and 12 months post-implant
12 months
Assessments at 3, 6, and 12 months post-implant
Participant Groups
The Networked Neuroprosthesis Device - Upper Extremity (NP-UE) is being tested for safety and effectiveness in helping people with cervical SCI to regain grasp-release functions of their hands.
1Treatment groups
Experimental Treatment
Group I: Experimental: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention
Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.
Networked Neuroprosthesis Device is already approved in United States for the following indications:
🇺🇸 Approved in United States as Networked Neuroprosthesis Device for:
- Upper extremity function in individuals with cervical spinal cord injury (SCI)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MetroHealth Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
MetroHealth Medical CenterLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Case Western Reserve UniversityCollaborator
References
Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. [2022]Implantable motor neuroprostheses can restore functionality to individuals with neurological disabilities by electrically activating paralyzed muscles in coordinated patterns. The typical design of neuroprosthetic systems relies on a single multi-use device, but this limits the number of stimulus and sensor channels that can be practically implemented. To address this limitation, a modular neuroprosthesis, the "Networked Neuroprosthesis" (NNP), was developed. The NNP system is the first fully implanted modular neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording, and stimulating components. This paper describes the design of stimulation and recording modules, bench testing to verify stimulus outputs and appropriate filtering and recording, and validation that the components function properly while implemented in persons with spinal cord injury. The results of system testing demonstrated that the NNP was functional and capable of generating stimulus pulses and recording myoelectric, temperature, and accelerometer signals. Based on the successful design, manufacturing, and testing of the NNP System, multiple clinical applications are anticipated.
A novel command signal for motor neuroprosthetic control. [2021]Neuroprostheses can restore functions such as hand grasp or standing to individuals with spinal cord injury (SCI) using electrical stimulation to elicit movements in paralyzed muscles. Implanted neuroprostheses currently use electromyographic (EMG) activity from muscles above the lesion that remain under volitional control as a command input. Systems in development use a networked approach and will allow for restoration of multiple functions but will require additional command signals to control the system, especially in individuals with high-level tetraplegia.
A review of methods for achieving upper limb movement following spinal cord injury through hybrid muscle stimulation and robotic assistance. [2020]Individuals with tetraplegia, typically attributed to spinal cord injuries (SCI) at the cervical level, experience significant health care costs and loss of independence due to their limited reaching and grasping capabilities. Neuromuscular electrical stimulation (NMES) is a promising intervention to restore arm and hand function because it activates a person's own paralyzed muscles; however, NMES sometimes lacks the accuracy and repeatability necessary to position the limb for functional tasks, and repeated muscle stimulation can lead to fatigue. Robotic devices have the potential to restore function when used as assistive devices to supplement or replace limited or lost function of the upper limb following SCI. Unfortunately, most robotic solutions are bulky or require significant power to operate, limiting their applicability to restore functional independence in a home environment. Combining NMES and robotic support systems into a single hybrid neuroprosthesis is compelling, since the robotic device can supplement the action of the muscles and improve repeatability and accuracy. Research groups have begun to explore applications of movement assistance for individuals with spinal cord injury using these technologies in concert. In this review, we present the state of the art in hybrid NMES-orthotic systems for upper limb movement restoration following spinal cord injury, and suggest areas for emphasis necessary to move the field forward. Currently, NMES-robotic systems use either surface or implanted electrodes to stimulate muscles, with rigid robotic supports holding the limb against gravity, or providing assistance in reaching movements. Usability of such systems outside of the lab or clinic is limited due to the complexity of both the mechanical components, stimulation systems, and human-machine interfaces. Assessment of system and participant performance is not reported in a standardized way. Future directions should address wearability through improvements in component technologies and user interfaces. Further, increased integration of the control action between NMES and robotic subsystems to reanimate the limb should be pursued. Standardized reporting of system performance and expanded clinical assessments of these systems are also needed. All of these advancements are critical to facilitate translation from lab to home.
Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. [2019]To test the efficacy and safety of the NESS Handmaster neuroprosthesis with subjects with C5 or C6 tetraplegia.
Implanted stimulators for restoration of function in spinal cord injury. [2019]Neuroprostheses that electrically stimulate paralyzed muscles provide functional enhancements for individuals with spinal cord injury and stroke such as standing and stepping, reaching and grasping, and bladder and bowel function. For chronic applications, implanted neuroprostheses lead to reliable, low-maintenance and patient-acceptable systems. The advantages of such systems are discussed followed by a generic description of implantable stimulators. Features of current first and second generation neuroprostheses developed at our centre are discussed followed by our experience in the application of these devices in the rehabilitation of individuals with spinal cord injury.
Neuroprosthetics and the science of patient input. [2019]Safe and effective neuroprosthetic systems are of great interest to both DARPA and CDRH, due to their innovative nature and their potential to aid severely disabled populations. By expanding what is possible in human-device interaction, these devices introduce new potential benefits and risks. Therefore patient input, which is increasingly important in weighing benefits and risks, is particularly relevant for this class of devices. FDA has been a significant contributor to an ongoing stakeholder conversation about the inclusion of the patient voice, working collaboratively to create a new framework for a patient-centered approach to medical device development. This framework is evolving through open dialogue with researcher and patient communities, investment in the science of patient input, and policymaking that is responsive to patient-centered data throughout the total product life cycle. In this commentary, we will discuss recent developments in patient-centered benefit-risk assessment and their relevance to the development of neural prosthetic systems.
An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. [2019]An advanced neuroprosthesis that provides control of grasp-release, forearm pronation, and elbow extension to persons with cervical level spinal cord injury is described. The neuroprosthesis includes implanted and external components. The implanted components are a 10-channel stimulator-telemeter, leads and electrodes, and a joint angle transducer; the external components are a control unit and transmitter-receiver coil. The system has completed preclinical testing and has been implanted fully in 3 persons and partially in 1 person, all with tetraplegia caused by spinal cord injury at C5 and C6. The minimum follow-up time for any system component is 16 months. All subjects had improvements in grasp strength, range of motion, and ability to grasp objects and increased independence in activities of daily living. Each subject became a regular user of the neuroprosthesis and is satisfied with it. The implanted components have not caused any medical complications. The operation of the electrodes and sensors has been stable. The data show that this advanced neuroprosthetic system is safe and can provide grasping and reaching ability to individuals with cervical level spinal cord injury.
Twenty year experience with implanted neuroprostheses. [2020]The long-term durability and safety of implanted devices is of great importance in the field of motor neuroprosthetics, where systems may possibly be utilized in excess of 50 years by some individuals. Neuroprosthetic systems have now been implanted in the upper extremity of spinal cord injured individuals for more than 20 years. The experience with these systems shows a high level of durability of the implanted components, particularly the stimulating electrodes and leads.