Intraoperative Non-invasive Eye Movement Monitoring

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: EEG Electrode Patch; Device: Standard Needles

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients determined by the PI

Description

Inclusion Criteria:

- Subject will be undergoing surgery involved of the nerves controlling the eye

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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 we would commonly use for recording.
Standard Needles; The current solution to monitor eye movement during surgery is to place standard needles in the muscles surrounding the eye.	Device: Standard Needles; Needles are placed in the muscles surrounding the eye to measure eye movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jamie J Van Gompel, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: EEG electrodes
• Other Study ID Numbers: 16-010266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No