Hand Function for Tetraplegia
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|ClinicalTrials.gov Identifier: NCT00890916|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2009
Results First Posted : February 8, 2017
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Tetraplegia||Device: FIRSTHAND System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hand Function for Tetraplegia Using a Wireless Neuroprosthesis|
|Actual Study Start Date :||January 1, 2012|
|Actual Primary Completion Date :||November 1, 2015|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Neuroprosthesis System
Receives implanted device for hand function.
Device: FIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
- Grasp Release Test - Test of Functional Ability to Pick up and Move Objects [ Time Frame: 6-9 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890916
|United States, Ohio|
|Louis Stokes VA Medical Center, Cleveland, OH|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Kevin L Kilgore, PhD||Louis Stokes VA Medical Center, Cleveland, OH|