Clinical trial NCT00583804: Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
Official title: Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Tetraplegia
Keywords: Spinal Cord Injury
Tetraplegia
Functional Electrical Stimulation
Neuroprosthesis
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: VA Office of Research and Development
name: FDA Office of Orphan Products Development
First posted: 2007-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grasp-Release Test
timeFrame: One Year
measure: Activities of Daily Living Test
timeFrame: Three months
Secondary outcomes:
measure: Adverse Events
timeFrame: From date of implant until study completion or date of death from any cause.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Kevin L Kilgore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peckham PH, Kilgore KL, Keith MW, Bryden AM, Bhadra N, Montague FW. An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. J Hand Surg Am. 2002 Mar;27(2):265-76. doi: 10.1053/jhsu.2002.30919.
citation: Kilgore KL, Bryden A, Keith MW, Hoyen HA, Hart RL, Nemunaitis GA, Peckham PH. Evolution of Neuroprosthetic Approaches to Restoration of Upper Extremity Function in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):252-264. doi: 10.1310/sci2403-252.
citation: Peckham PH, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulcahey MJ, Carroll S, Hentz VR, Wiegner A; Implantable Neuroprosthesis Research Group. Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2001 Oct;82(10):1380-8. doi: 10.1053/apmr.2001.25910.
citation: Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.