Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch

A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring

The goal of this study is to test if a non-invasive patch can safely monitor facial nerve activity in adults during parotid or facial surgery. Monitoring the facial nerve during these surgeries helps lower the risk of nerve injury and possible functional and aesthetic damage. Current methods use small needles and require careful placement, which can be difficult and may affect how well they work.

The aims to answer the following questions:

• Can the patch provide similar results to the standard monitoring method?
• Is the patch safe and easy to use during surgery?

The research team will compare the readings from the patch with those from the standard method used during surgery.

Participants will:

• Undergo their planned surgery as usual
• Have a patch placed on the face before the surgery
• Have both the standard method and the patch monitor the facial nerve during surgery
• Have the data extracted from the monitoring tools and analyzed without personal identifying information.

All the decisions during surgery will be based only on the standard method.

Study Overview

• Status: Not yet recruiting
• Conditions: Facial and Neck Rhytides; Parotid Gland Tumor
• Intervention / Treatment: Device: Non-invasive facial nerve monitoring patch

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 99 years
• Hebrew speakers
• Ability to understand the study requirements and provide informed consent
• Ability to cooperate with the research team throughout the study procedures

Exclusion Criteria:

• Current or past comorbidity affecting facial nerve function
• Previous injection of botulinum toxin to the face
• Skin conditions that may interfere with the placement or function of the investigational patch, according to the manufacturer's guidelines
• Known allergy to any component of the dry electrode patch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Dual Facial Nerve Monitoring; Participants will undergo intraoperative facial nerve monitoring using the standard monitoring method along with a non-invasive patch applied to the face. Both methods will be used during the same surgery for all participants, and clinical decisions will be based solely on the standard monitoring method.

Device: Non-invasive facial nerve monitoring patch; A non-invasive surface electrode patch applied to the face to continuously monitor facial nerve activity during surgery. The patch uses dry electrodes to detect electrical signals associated with nerve stimulation and muscle activity. Data are recorded throughout the procedure for analysis. The patch operates in parallel with the standard monitoring method and does not influence clinical decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between the patch and the standard monitoring tool in detecting facial nerve activity	Agreement between the non-invasive patch and the standard monitoring method in detecting facial nerve activity during surgery. Agreement evaluation will be based on concordance in detection and temporal correlation of nerve responses recorded by both methods during intraoperative stimulation.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of non-invasive patch use	Evaluation of device-related adverse effects associated with the use of the non-invasive facial nerve monitoring patch during surgery, including skin reactions or other local adverse effects.	During surgery
Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring	Subjective assessment regarding the usability and integration of the patch during surgery	During surgery

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 18, 2027
• Study Completion (Estimated): February 18, 2028

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Head and Neck Neoplasms; Salivary Gland Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Pathological Conditions, Signs and Symptoms; Facies; Parotid Neoplasms
• Other Study ID Numbers: SHEBA-26-2695-EA-CTIL

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.: No