Overview

This trial is active, not recruiting.

Conditions spinal cord injury, tetraplegia
Treatment firsthand system
Phase phase 1/phase 2
Sponsor VA Office of Research and Development
Start date January 2012
End date November 2015
Trial size 7 participants
Trial identifier NCT00890916, A6027-R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Receives implanted device for hand function.
firsthand system
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.

Primary Outcomes

Measure
Grasp Release Test - test of functional ability to pick up and move objects
time frame: 6-9 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - cervical level spinal cord injury; - complete paralysis of fingers and thumbs; - voluntary shoulder motion; - electrically excitable forearm and hand musculature Exclusion Criteria: - extreme contractures of the joints; - skeletal immaturity; - extensive denervation in the forearm and hand; - poor surgical risk

Additional Information

Official title Hand Function for Tetraplegia Using a Wireless Neuroprosthesis
Principal investigator Kevin L Kilgore, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.