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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FIRSTHAND System

Device

Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.

Primary outcomes

Grasp Release Test - Test of Functional Ability to Pick up and Move Objects

Time frame: 6-9 weeks

Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Hand Function for Tetraplegia Using a Wireless Neuroprosthesis

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2021
First posted: Apr 30, 2009
Registry last updated: Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed