Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Hand Function for Tetraplegia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: April 27, 2009
Last updated: April 22, 2016
Last verified: April 2016
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
Device: FIRSTHAND System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00890916

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

Additional Information:
Responsible Party: VA Office of Research and Development Identifier: NCT00890916     History of Changes
Other Study ID Numbers: A6027-R 
Study First Received: April 27, 2009
Last Updated: April 22, 2016
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms processed this record on January 14, 2017