Trials / Recruiting

RecruitingNCT02329652

Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: Anne Bryden · Academic / Other
Sex: All
Age: 17 Years
Healthy volunteers: Not accepted

Summary

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

Detailed description

The goal of this project is to restore these multiple functions to these individuals through a comprehensive neuroprosthetic approach that addresses the overall needs of the individual. This approach involves all aspects of the implementation, including the implanted technology, the surgical installation, and the outcomes assessment through a coordinated team approach in order to maximize the functional independence gained by the individual. With this system, we propose that individuals who have a mid-cervical-level spinal cord injury will regain control over multiple functions, including grasp, reach, bed mobility, seated posture, restoration of an effective cough and bladder function. This ambitious and exciting goal is made possible by the culmination of our research and clinical deployment of neuroprosthetic systems for spinal cord injured subjects over the past 30 years. We anticipate that this system will not only provide increased independence in each of the targeted body functions, but will provide enough of an overall benefit to demonstrate significant improvements in quality of life and health outcomes. In clinical feasibility studies with spinal cord injured subjects, our clinical research teams have demonstrated the control of bilateral hand function, bed mobility, postural control, restoration of an effective cough, and bladder control using chronically implanted neuroprostheses. Outcomes from each clinical study demonstrate that each system provides increased functional independence to the individual. Initially, only a single type of implanted system was implemented in any one individual, resulting in restoration of a single bodily function. Thus, it has been necessary for subjects to choose between available functions and select only one, despite the fact that each subject had multiple disabilities. In the past few years, we have progressed to implementing a few subjects with more than one system, such as providing both hand function and trunk stability. However, the fundamental limitation of the current approach has been technological; i.e. each implanted system is completely independent (both technically and programmatically), requiring separate technology to be developed for each function, and these systems are implemented by separate teams in separate surgical procedures. Thus, to this point, it has not been possible to address each individual's comprehensive needs and tailor an overall approach that maximizes their functional gains. The proposed approach depends on the availability of a foundational platform technology that is capable of meeting our broad specifications. We have now achieved this milestone under separate funding, creating a revolutionary new implantable neuroprosthetic technology that is fully capable of providing the necessary technological base for our proposed research. This system, the Networked Neuroprosthetic System (NNPS), is a modular, scalable, and configurable network of fully implanted, networked modules capable of meeting or exceeding the needs of all of these neuroprosthetic applications. The NNPS provides a foundation which enables efficient technical refinements that optimize implementation of the system for each targeted application. The NNPS technology is currently operational and is undergoing fabrication and testing in preparation for final pre-clinical studies and human implantation.

Conditions

Interventions

Type	Name	Description
DEVICE	Networked Neuroprosthetic System for Grasp and Trunk	Receive implanted networked neuroprosthesis

Timeline

Start date: 2014-12-01
Primary completion: 2028-12-31
Completion: 2031-12-31
First posted: 2014-12-31
Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT02329652. Inclusion in this directory is not an endorsement.