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For procedures involving proximity to the nerves responsible for eye movement, the need to monitor eye movement exists. The current solution is to place needles in the muscles surrounding the eye. The Investigators have invented a non-invasive electrode and software designed to monitor eye movements non-invasively. The electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects the horizontal and vertical movements of the eye. The Investigators would like to prove efficacy compared to the standard monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEG Electrode Patch | The additional electrodes are modified EEG electrodes (used in clinical practice on the head already) placed in a silicone molding. These are placed lateral to the eye with the patient asleep. These are then wired to the same recording apparatus that is commonly used for recording. |
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| Standard Needles | The current solution to monitor eye movement during surgery is to place standard needles in the muscles surrounding the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG Electrode Patch | Device | The additional electrodes are modified EEG electrodes (used in clinical practice on the head already) placed in a silicone molding. These are placed lateral to the eye with the patient asleep. These are then wired to the same recording apparatus that we would commonly use for recording. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with greater than 95% concordance in signal between the standard needles and EEG electrode patch | The current method of measuring eye movement is to place needles in the muscles surrounding the eye. For the non-invasive method, the electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects horizontal and vertical movements of the eye. The signal comparison for the two methods would be a biphasic dipole representing eye movements compared to the compound muscle action potential of the invasive method. | approximately 30 minutes |
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Inclusion Criteria:
- Subject will be undergoing surgery involved of the nerves controlling the eye
Exclusion Criteria:
- None
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Surgical patients determined by the PI
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| Name | Affiliation | Role |
|---|---|---|
| Jamie J Van Gompel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Standard Needles | Device | Needles are placed in the muscles surrounding the eye to measure eye movements. |
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