A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sheba Medical Center
- Enrollment
- 20
- Primary Endpoint
- Agreement between the patch and the standard monitoring tool in detecting facial nerve activity
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Non-invasive facial nerve monitoring patch (Device)
Outcomes
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(During surgery)
- Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring(During surgery)
Investigators
Dr. Mor Peri Bitterman
physician
Sheba Medical Center