Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury (NNP-UE+T)
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|ClinicalTrials.gov Identifier: NCT02329652|
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : August 18, 2020
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.
FDA OOPD NIH NINDS
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Spinal Cord Injury at C5-C7 Level Spinal Cord Injury Cervical Spinal Cord Injury at C5-C7 Level With Complete Lesion Spinal Cord Injury at C5-C7 Level With Incomplete Lesion||Device: Networked Neuroprosthetic System for Grasp and Trunk||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||December 2029|
Experimental: Intervention - implant neuroprosthesis
Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.
Device: Networked Neuroprosthetic System for Grasp and Trunk
Receive implanted networked neuroprosthesis
- Activities of Daily Living Abilities Test [ Time Frame: Three months post-implant ]Evaluation of ability to perform activities of daily living when using the neuroprosthesis compared to ability when the neuroprosthesis is turned off.
- Grasp-Release Test [ Time Frame: Pre-implant and three months post-implant ]Ability to pick up, move, and release six standard objects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329652
|United States, Ohio|
|MetroHealth Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Kevin L Kilgore, Ph.D. UE.FES.ClinicalTrials@gmail.com|
|Principal Investigator: Kevin L Kilgore, Ph.D.|