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.
|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|
- 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 ]
- Adverse Events [ Time Frame: Subject lifetime ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 1989|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Individuals implanted with stimulator/sensor device.
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583804
|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, 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|