Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 28, 2014
Last verified: July 2014

December 20, 2007
July 28, 2014
April 1989
July 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00583804 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: Subject lifetime ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spinal Cord Injury
  • Tetraplegia
Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
Experimental: 1
Individuals implanted with stimulator/sensor device.
Intervention: Device: IST-12

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2017
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United States
 
NCT00583804
IST12-PHP-2004, VA Merit Review A3707R
No
Kevin Kilgore, MetroHealth Medical Center
MetroHealth Medical Center
  • Case Western Reserve University
  • Department of Veterans Affairs
  • FDA Office of Orphan Products Development
Principal Investigator: Kevin L Kilgore, Ph.D. MetroHealth Medical Center
MetroHealth Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP