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

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ClinicalTrials.gov Identifier: NCT00583804
Recruitment Status : Active, not recruiting
First Posted : December 31, 2007
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Case Western Reserve University
VA Office of Research and Development
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
Kevin Kilgore, MetroHealth Medical Center

December 20, 2007
December 31, 2007
May 1, 2017
June 8, 2018
June 8, 2018
April 1989
January 2015   (Final data collection date for primary outcome measure)
  • Grasp-Release Test [ Time Frame: One Year ]
    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.
  • Activities of Daily Living Test [ Time Frame: Three months ]
    Evaluation of independence and performance for at least six activities of daily living, including eating with a fork, drinking from a cup, etc.
  • Grasp-Release Test [ Time Frame: One Year ]
  • Activities of Daily Living Test [ Time Frame: Three months ]
Complete list of historical versions of study NCT00583804 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: From date of implant until study completion or date of death from any cause. ]
Self-reported adverse events.
Adverse Events [ Time Frame: Subject lifetime ]
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.

The device is referred to as the Implanted Stimulator-Telemeter (IST) -12. The device uses functional electrical stimulation (FES) to activate paralyzed muscles.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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: Stimulation ON
    Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.
    Intervention: Device: IST-12
  • Active Comparator: Stimulation OFF
    Function with stimulation turned off.
    Intervention: Device: IST-12

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
50
January 2019
January 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00583804
IRB89-00027
VA Merit Review A3707R ( Other Grant/Funding Number: Dept. Veterans Affairs )
No
Not Provided
Not Provided
Kevin Kilgore, MetroHealth Medical Center
MetroHealth Medical Center
  • Case Western Reserve University
  • VA Office of Research and Development
  • FDA Office of Orphan Products Development
Principal Investigator: Kevin L Kilgore, Ph.D. MetroHealth Medical Center
MetroHealth Medical Center
May 2018

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