Hand Function for Tetraplegia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/13/2018 |
| Start Date: | January 1, 2012 |
| End Date: | December 31, 2019 |
Hand Function for Tetraplegia Using a Wireless Neuroprosthesis
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.
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.
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 known 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.
individuals with cervical-level spinal cord injury through the use of an advanced wireless
myoelectrically controlled battery-powered implanted neuroprosthetic system known 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.
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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