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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583804
Recruitment Status : Active, not recruiting
First Posted : December 31, 2007
Results First Posted : June 8, 2018
Last Update Posted : August 28, 2019
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

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Tetraplegia Device: IST-12 Not Applicable

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
Actual Study Start Date : April 1, 1989
Actual Primary Completion Date : January 1, 2015
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Stimulation ON
Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.
Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.

Active Comparator: Stimulation OFF
Function with stimulation turned off.
Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.

Primary Outcome Measures :
  1. 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.

  2. Activities of Daily Living Test [ Time Frame: Three months ]
    The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) "Physical Assistance" (PA): assistance from an attendant, 2) "Adaptive Equipment" (AE): any modifications of the activity or its components, 3) "Orthotic Assistance" (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) "Self Assistance" (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) "Independent".

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: From date of implant until study completion or date of death from any cause. ]
    Self-reported adverse events.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583804

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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Case Western Reserve University
VA Office of Research and Development
FDA Office of Orphan Products Development
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Principal Investigator: Kevin L Kilgore, Ph.D. MetroHealth Medical Center
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Kevin Kilgore, Program Manager, MetroHealth Medical Center Identifier: NCT00583804    
Other Study ID Numbers: IRB89-00027
VA Merit Review A3707R ( Other Grant/Funding Number: Dept. Veterans Affairs )
First Posted: December 31, 2007    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Kevin Kilgore, MetroHealth Medical Center:
Spinal Cord Injury
Functional Electrical Stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Signs and Symptoms