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Sponsors and Collaborators: |
MetroHealth Medical Center Case Western Reserve University Department of Veterans Affairs FDA Office of Orphan Products Development |
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Information provided by: | MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT00583804 |
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 |
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Spinal Cord Injury Tetraplegia |
Device: IST-12 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury |
Estimated Enrollment: | 50 |
Study Start Date: | April 1989 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Individuals implanted with stimulator/sensor device.
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Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Beth Lipka | 216-778-4312 | marybeth.lipka@case.edu |
Contact: Kevin L Kilgore, Ph.D. | 216-778-3801 | klk4@case.edu |
United States, Ohio | |
MetroHealth Medical Center | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Principal Investigator: Kevin L Kilgore, Ph.D. |
Principal Investigator: | Kevin L Kilgore, Ph.D. | MetroHealth Medical Center |
Responsible Party: | MetroHealth Medical Center ( Kevin Kilgore/Principal Investigator ) |
Study ID Numbers: | IST12-PHP-2004, VA Merit Review A3707R |
Study First Received: | December 20, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00583804 |
Health Authority: | United States: Food and Drug Administration |
Spinal Cord Injury Tetraplegia Functional Electrical Stimulation Neuroprosthesis |
Paralysis Signs and Symptoms Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Neurologic Manifestations Trauma, Nervous System Quadriplegia |
Nervous System Diseases |