Hand Function for Tetraplegia

Hand Function for Tetraplegia Using a Wireless Neuroprosthesis

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury; Tetraplegia
• Intervention / Treatment: Device: FIRSTHAND System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neuroprosthesis System; Receives implanted device for hand function.	Device: FIRSTHAND System; Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grasp Release Test - Test of Functional Ability to Pick up and Move Objects	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.	6-9 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kevin L Kilgore, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Publications and helpful links

General Publications

• Peckham PH, Kilgore KL. Challenges and opportunities in restoring function after paralysis. IEEE Trans Biomed Eng. 2013 Mar;60(3):602-9. doi: 10.1109/TBME.2013.2245128. Epub 2013 Mar 7.
• Kilgore KL, Bryden A, Keith MW, Hoyen HA, Hart RL, Nemunaitis GA, Peckham PH. Evolution of Neuroprosthetic Approaches to Restoration of Upper Extremity Function in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):252-264. doi: 10.1310/sci2403-252.
• Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.

Helpful Links

• Cleveland FES Center website - research into restoring movement using neuroprostheses

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 29, 2009
• First Posted (ESTIMATE): April 30, 2009

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: functional electrical stimulation; spinal cord injury; quadriplegia; neuroprosthesis
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: A6027-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes