Intraoperative Non-invasive Eye Movement Monitoring

NCT03046615 | Completed

• 1 other identifier: 16-010266
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Keywords

EEG electrodes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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.

EEG Electrode Patch

Standard Needles DEVICE

Needles are placed in the muscles surrounding the eye to measure eye movements.

Standard Needles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients determined by the PI

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Jamie J Van Gompel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery and Otolaryngology

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 8, 2017
• Study Start: February 13, 2017
• Primary Completion: August 31, 2018
• Study Completion: January 31, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

US (1)