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Hand Function for Tetraplegia - NCT00890916-44106(Clinical Trial 289545)



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City:  Cleveland
State:  
OH
Zip Code: 44106
Conditions: Spinal Cord Injury - Tetraplegia
Purpose: 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.
Study summary: The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system know as the "FIRSTHAND" System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.
Criteria: Inclusion Criteria: - cervical level spinal cord injury; - complete paralysis of fingers and thumbs; - voluntary shoulder motion; - electrically excitable forearm and hand musculature Exclusion Criteria: - extreme contractures of the joints; - skeletal immaturity; - extensive denervation in the forearm and hand; - poor surgical risk
Study is available at: VA Medical Center, Cleveland
Cleveland, OH 44106
United States

Primary Contact:
Mary Beth Lipka
Email: mary.lipka@va.gov
Phone: (216) 791-3800
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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