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

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.

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Key information

Conditions

Parotid Gland Tumor Disease Attributes Facial and Neck Rhytides Facies Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Parotid Diseases Parotid Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive facial nerve monitoring patch

Device

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.

Primary outcomes

Agreement between the patch and the standard monitoring tool in detecting facial nerve activity

Time frame: During surgery

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.

Secondary outcomes

Safety of non-invasive patch use

Time frame: During surgery

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.
Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring

Time frame: During surgery

Subjective assessment regarding the usability and integration of the patch during surgery

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Apr 13, 2026
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed