Hand Function for Tetraplegia
The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.
Spinal Cord Injury
Device: FIRSTHAND System
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hand Function for Tetraplegia Using a Wireless Neuroprosthesis|
- Grasp Release Test - test of functional ability to pick up and move objects [ Time Frame: 6-9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Receives implanted device for hand function.
Device: FIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system known as the "FIRSTHAND" System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890916
|United States, Ohio|
|Louis Stokes VA Medical Center, Cleveland, OH|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Kevin L. Kilgore, PhD||Louis Stokes VA Medical Center, Cleveland, OH|