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Hand Function for Tetraplegia

NCT00890916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-06-09

Study results available
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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.

Conditions

  • Spinal Cord Injury
  • Tetraplegia

Interventions

DEVICE

FIRSTHAND System

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Kevin L Kilgore, PhD · Louis Stokes VA Medical Center, Cleveland, OH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2015-11-01
Completion
2021-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890916 on ClinicalTrials.gov