Neuroprosthetic System for Spinal Cord Injury
(NNP-UE+T Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like severe cardiopulmonary disease or are on medications that interact with implantable devices, you might need to discuss this with the trial team.
Is the Networked Neuroprosthetic System safe for humans?
How is the Networked Neuroprosthetic System treatment different from other treatments for spinal cord injury?
The Networked Neuroprosthetic System (NNP) is unique because it is a fully implanted modular system that can restore multiple functions by electrically activating paralyzed muscles in coordinated patterns. Unlike traditional single-device neuroprostheses, the NNP uses a networked approach with multiple modules for power, signal processing, and stimulation, allowing for more complex and customizable control of muscle movements.12678
What data supports the effectiveness of the treatment Networked Neuroprosthetic System for Grasp and Trunk in individuals with spinal cord injury?
Research shows that the Networked Neuroprosthesis (NNP) system is functional and capable of generating stimulus pulses and recording signals, and an advanced neuroprosthesis has been shown to improve grasp strength, range of motion, and independence in daily activities for individuals with cervical level spinal cord injury, with no medical complications reported.12367
Are You a Good Fit for This Trial?
This trial is for individuals over 16 years old with cervical spinal cord injuries (C4-C8 level, AIS grade A-D) who are at least six months post-injury. Participants must have some arm and trunk muscle strength, be medically stable for surgery, and willing to participate. Pregnant women, those with certain neurological conditions or severe diseases, active infections, or other implantable devices are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Assessment
Participants receive the implanted networked neuroprosthetic system and undergo initial functional training and assessment
Functional Training and Assessment
Participants undergo functional training and assessment to optimize the use of the neuroprosthetic system for hand, arm, and trunk function
Follow-up
Participants are monitored for safety and effectiveness after the initial training and assessment phase
What Are the Treatments Tested in This Trial?
Interventions
- Networked Neuroprosthetic System for Grasp and Trunk
Networked Neuroprosthetic System for Grasp and Trunk is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kevin Kilgore
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Case Western Reserve University
Collaborator
FDA Orphan Products Division
Collaborator