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

NCT00583804 | Active Not Recruiting Results

• 2 other identifiers: IRB89-00027VA Merit Review A3707R
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Tetraplegia

Keywords

Spinal Cord Injury; Tetraplegia; Functional Electrical Stimulation; Neuroprosthesis

Outcome Measures

Primary Outcomes (2)

• Grasp-Release Test

  Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) \[Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004\], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers \[Peckham, 2001\]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (\~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.

  One Year

• Activities of Daily Living Test

  The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) "Physical Assistance" (PA): assistance from an attendant, 2) "Adaptive Equipment" (AE): any modifications of the activity or its components, 3) "Orthotic Assistance" (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) "Self Assistance" (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) "Independent".

  Three months

Secondary Outcomes (1)

• Adverse Events

  From date of implant until study completion or date of death from any cause.

Study Arms (2)

Stimulation ON

EXPERIMENTAL

Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.

Device: IST-12

Stimulation OFF

ACTIVE COMPARATOR

Function with stimulation turned off.

Device: IST-12

Interventions

IST-12 DEVICE

Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.

Stimulation OFF; Stimulation ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• C5-C8 spinal cord injury
• Minimum of one-year post injury with no additional function prior to implantation surgery
• Male or female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Case Western Reserve University: collaborator
• VA Office of Research and Development: collaborator
• FDA Office of Orphan Products Development: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (4)

• 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.

  PMID: 11901386 BACKGROUND

• 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.

  PMID: 29997428 BACKGROUND

• 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.

  PMID: 11588741 RESULT

• 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.

  PMID: 18406958 RESULT

Related Links

• Cleveland FES Center

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: MetroHealth Medical Center

ue.fes.clinicaltrials@gmail.com

2169573683

Study Officials

• Kevin L Kilgore, Ph.D.

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Manager

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: April 1, 1989
• Primary Completion: January 1, 2015
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 3, 2025
• Results First Posted: June 8, 2018

Record last verified: 2025-09

Locations

US (1)