NCT00890916

Brief Summary

The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 8, 2017

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 9, 2021

Status Verified

May 1, 2021

Enrollment Period

3.8 years

First QC Date

April 27, 2009

Results QC Date

October 17, 2016

Last Update Submit

May 21, 2021

Conditions

Spinal Cord InjuryTetraplegia

Keywords

spinal cord injuryneuroprosthesisfunctional electrical stimulationquadriplegia

Outcome Measures

Primary Outcomes (1)

  • Grasp Release Test - Test of Functional Ability to Pick up and Move Objects

    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.

    6-9 weeks

Study Arms (1)

Neuroprosthesis System

EXPERIMENTAL

Receives implanted device for hand function.

Device: FIRSTHAND System

Interventions

FIRSTHAND SystemDEVICE

Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.

Neuroprosthesis System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cervical level spinal cord injury;
  • complete paralysis of fingers and thumbs;
  • voluntary shoulder motion;
  • electrically excitable forearm and hand musculature

You may not qualify if:

  • extreme contractures of the joints;
  • skeletal immaturity;
  • extensive denervation in the forearm and hand;
  • poor surgical risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

  • Peckham PH, Kilgore KL. Challenges and opportunities in restoring function after paralysis. IEEE Trans Biomed Eng. 2013 Mar;60(3):602-9. doi: 10.1109/TBME.2013.2245128. Epub 2013 Mar 7.

    PMID: 23481680BACKGROUND

  • 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: 29997428RESULT

  • 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: 18406958RESULT

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Kevin Kilgore
Organization
Louis Stokes Cleveland VAMC
klk4@case.edu
216-9573657

Study Officials

  • Kevin L Kilgore, PhD

    Louis Stokes VA Medical Center, Cleveland, OH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 30, 2009

Study Start

January 1, 2012

Primary Completion

November 1, 2015

Study Completion

May 1, 2021

Last Updated

June 9, 2021

Results First Posted

February 8, 2017

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)