Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy

Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy

The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.

Study Overview

• Status: Terminated
• Conditions: Parotid Gland Disorders
• Intervention / Treatment: Device: APS electrode; Device: Facial Nerve Monitor

Detailed Description

This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events.

In the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

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

Description

Inclusion Criteria:

• Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
• Benign or malignant disease

Exclusion Criteria:

• Current pregnancy
• Preoperative facial nerve dysfunction
• Revision surgery
• History of preoperative radiation to the surgical field
• Retrograde or extracapsular dissection
• Intentional nerve sacrifice (i.e., due to nerve involvement by tumor)
• Tumors with proximity to main trunk of facial nerve
• Inability to place electrode
• Presence of electrode alters surgical technique

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Facial Nerve Monitoring with APS electrode; The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating(APS) electrode during parotidectomy surgery.

Device: APS electrode; The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.; Other Names: automatic periodic stimulating (APS) Electrode Stimulator; Device: Facial Nerve Monitor; The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.; Other Names: NIM-Response 3.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Electromyography (EMG)	EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.	baseline, approximately 3 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Medtronic
• Investigators: Principal Investigator: Eric J Moore, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Parotidectomy
• Other Study ID Numbers: 16-009380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes