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Hand Function for Tetraplegia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00890916
First Posted: April 30, 2009
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention Phase
Spinal Cord Injury Tetraplegia Device: FIRSTHAND System Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hand Function for Tetraplegia Using a Wireless Neuroprosthesis

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Enrollment: 11
Actual Study Start Date: January 1, 2012
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: November 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neuroprosthesis System
Receives implanted device for hand function.
Device: FIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890916


Locations
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kevin L Kilgore, PhD Louis Stokes VA Medical Center, Cleveland, OH
  More Information

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00890916     History of Changes
Other Study ID Numbers: A6027-R
First Submitted: April 27, 2009
First Posted: April 30, 2009
Results First Submitted: October 17, 2016
Results First Posted: February 8, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by VA Office of Research and Development:
spinal cord injury
neuroprosthesis
functional electrical stimulation
quadriplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms