Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

This study is currently recruiting participants.
Verified November 2012 by MetroHealth Medical Center
Sponsor:
Collaborators:
Case Western Reserve University
Information provided by (Responsible Party):
Kevin Kilgore, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00583804
First received: December 20, 2007
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.


Condition Intervention
Spinal Cord Injury
Tetraplegia
Device: IST-12

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • Grasp-Release Test [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Activities of Daily Living Test [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Subject lifetime ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 1989
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Individuals implanted with stimulator/sensor device.
Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.

Detailed Description:

The design of this study is to determine the efficacy of improving upper extremity function in tetraplegic subjects after receiving an implantable device for neuromuscular control. Evaluations will be made so as to document changes in performance of manipulative tasks when using the stimulation system.

Subjects who consent to participate in this project will have an implantable stimulator surgically placed in the upper extremity for control of the upper extremity. A series of tests will be performed before implantation, and repeated at intervals after implantation to assess changes in each subject's performance.

This study is a non-randomized feasibility study with concurrent (neuroprosthesis on and off) and longitudinal (pre- and post-implantation/training) self-controls.

Subjects participating in the study can expect to be actively involved in the study for two years after implantation and followed for life thereafter. The screening procedures take up to two days, depending on the specific evaluations necessary to determine candidacy. Pre-surgical exercise is conducted for at least two weeks. The implantation surgery itself lasts one day, with three to seven days of post-surgical hospitalization. Following an eight-week exercise program and a twelve-week training program, subjects are discharged from the active rehabilitation phase. They are followed quarterly for one year, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • C5-C8 spinal cord injury
  • Minimum of one-year post injury with no additional function prior to implantation surgery
  • Male or female
  • 18-60 years of age
  • intact vision
  • pharmacologically controlled spasticity, when applicable
  • Functional in wheelchair with adequate trunk support to allow bimanual manipulation
  • Positive attitude and motivation with supportive home environment
  • Willingness to return to laboratory for periodic evaluation and testing
  • Free of contractures known to diminish performance of the system (e.g., supination contracture of the wrist).
  • Integrity of the lower motor neuron (peripheral nerve) to the muscles to be activated
  • Adequate range of motion of joints of the shoulder, wrist, and hand (upper extremity).
  • If an acute infection is present, the subject will not be considered for surgery until it clears.

Exclusion Criteria:

  • Prior history of a major chronic systemic infection or other illness that would increase the risk of surgery.
  • Contraindications include immunologic diseases, cardiac arrhythmias, undiagnosed or high-risk breast masses, dermatologic conditions, and any major system failure.
  • Acute infection currently present that has not cleared.
  • Hypersensitivity that inhibits their ability to sustain pressure over their digits.
  • Blind
  • Uncontrolled disorders, i.e., seizures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583804

Contacts
Contact: Anne M Bryden 216-778-3480 UE.FES.ClinicalTrials@gmail.com
Contact: Kevin L Kilgore, Ph.D. 216-778-3480 UE.FES.ClinicalTrials@gmail.com

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Kevin L Kilgore, Ph.D.         
Sponsors and Collaborators
MetroHealth Medical Center
Case Western Reserve University
Investigators
Principal Investigator: Kevin L Kilgore, Ph.D. MetroHealth Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Kevin Kilgore, Program Manager, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00583804     History of Changes
Other Study ID Numbers: IST12-PHP-2004, VA Merit Review A3707R
Study First Received: December 20, 2007
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MetroHealth Medical Center:
Spinal Cord Injury
Tetraplegia
Functional Electrical Stimulation
Neuroprosthesis

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

ClinicalTrials.gov processed this record on April 15, 2014