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

MetroHealth Medical Center

Status

Active, not recruiting

Conditions

Tetraplegia

Spinal Cord Injury

Treatments

Device: IST-12

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00583804

IRB89-00027

VA Merit Review A3707R (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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