Hand Function for Tetraplegia - NCT00890916-44106 (Clinical Trial 289545)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy289545.aspx
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| City: |
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Cleveland |
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State:
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OH |
| Zip Code: |
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44106 |
| Conditions: |
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Spinal Cord Injury - Tetraplegia |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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VA Medical Center, Cleveland
Cleveland, OH 44106
United States
Primary Contact:
Mary Beth Lipka
Email: mary.lipka@va.gov
Phone: (216) 791-3800 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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