Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|
|
Spinal Cord Injury Tetraplegia |
Device: IST-12 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 1989 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Individuals implanted with stimulator/sensor device.
|
Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Kevin Kilgore, Program Manager, MetroHealth Medical Center |
| ClinicalTrials.gov Identifier: | NCT00583804 History of Changes |
| Other Study ID Numbers: | IST12-PHP-2004, VA Merit Review A3707R |
| Study First Received: | December 20, 2007 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MetroHealth Medical Center:
|
Spinal Cord Injury Tetraplegia Functional Electrical Stimulation Neuroprosthesis |
Additional relevant MeSH terms:
|
Quadriplegia Spinal Cord Injuries Paralysis Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013