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

Parotid Gland Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03172520
• Other study ID #: 16-009380
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parotid Gland Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials