Clinical Trial: Hand Function for Tetraplegia
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Hand Function for Tetraplegia Using a Wireless Neuroprosthesis
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: VA Office of Research and Development
Current Primary Outcome: Grasp Release Test - Test of Functional Ability to Pick up and Move Objects [ Time Frame: 6-9 weeks ]
Original Primary Outcome: Grasp Release Test - Test of Functional Ability to Pick up and Move Objects [ Time Frame: 6-9 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: VA Office of Research and Development
Dates:
Date Received: April 27, 2009
Date Started: January 2012
Date Completion: December 2017
Last Updated: December 15, 2016
Last Verified: December 2016