Blink Restoration in Patients With Facial Nerve Palsy (NEURO-BLINK)

This study is a non-blinded single armed pilot study aiming to apply a newly created medical device in patients with seventh nerve palsy suffering from lagophthalmus in order to determine the best way for neuromuscular stimulation of the orbicularis oculi muscle and facial nerve in order to enable eyelid closure (blink). Initially, a tailored external neurostimulation prototype will be created in collaboration with the ETH for patients with facial nerve palsy and lagophthalmos. Aim of this study is to create an efficient, safe and comfortable medical device that can achieve an effective blinking through external electrical neuromuscular stimulation of the orbicularis oculi in patients with facial palsy and lagophthalmos. Such a device can become an essential part of facial palsy treatment.

Study Overview

• Status: Completed
• Conditions: Facial Nerve Palsy
• Intervention / Treatment: Device: NEURO-BLINK Device

Detailed Description

Facial paralysis rates are reported to be 4/10,000 per annum leading to facial asymmetry and impairs essential facial functions, including blinking, protection of the cornea, lip competence, mastication, speaking, but also has psychosocial penalties.

Facial animation is orchestrated by the facial muscles directed by the facial nucleus through a network of the facial nerve and its branches. The facial nerve (CNVII) plays a critical role in multiple complex functions of human life including mastication, speech, and successful social communication through expression of mood and emotion. The absence of facial nerve's function can be a result of a developmental anomaly, of a stroke leading to a damage to the central segment of this nerve (facial nucleus in the pons, motor cortex, or connections between the two), an iatrogenic or traumatic injury, a neoplastic infiltration or an infectious (e.g., borreliosis and herpes zoster), or idiopathic inflammation of the extratemporal segments of the facial nerve. The peripheral facial paralysis (PFP), resulting from affection of the seventh nerve is the most common pathology of the cranial pairs.

The facial nerve normally emits electrical impulses to give muscles their tone and shape. Therefore, when it is damaged, the muscles become weak and floppy. External electrical stimulation can mimic the electrical nerve impulses and help restore muscle tone in patients with facial palsy. Applications involving nerve stimulation can be divided into three separate categories: therapeutic electrical stimulation (TES), neuromodulatory stimulation (NMS), and functional electrical stimulation (FES). By FES standards, neural prosthetic reanimation of the eyelids for blink restoration is a relatively simple and low-risk application. Restoration of blinking involves a single muscle, the orbicularis oculi. The presence of the nerve is not required for external electrical stimulation to be used.

External electrical neuromuscular stimulation can try to mimic the electrical nerve impulses in patients with facial palsy. However, no device has yet been proven appropriate for daily use. The research question the investigators aim to answer is whether an efficient, safe and comfortable medical device that can achieve an effective blinking through external electrical neuromuscular stimulation of the orbicularis oculi in patients with facial palsy and lagophthalmos can be created. The stimulation will be provided in the form of charge balanced biphasic square pulses as shown in the image below at a frequency of 100Hz. The investigators mainly want to determine the functionality of a constant external electrostimulation for the patients. Blinking sufficiency will be evaluated qualitatively and quantitatively through surveys and observations.

The investigators aim to recruit initially 10 patients suffering from lagophthalmos due to facial nerve palsy, who will be invited to wear the device. The exact parameters needed for the neurostimulation and symptoms of patients or any adverse events will be documented on the case report form (CRF).

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

Contacts and Locations

Study Locations

• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Ophthalmology Department Cantonal Hospital Aarau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 18
• Facial palsy
• Lagophthalmus

Exclusion Criteria:

• Minors
• Pacemaker or defibrillator
• Vulnerable population
• Patients in emergency situations
• Allergies on the sticky electrodes and MD metallic sensors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Patients with facial nerve palsy and lagophthalmus; There is only one arm in this study. The investigators examine if the medical device can achieve a painless blinking in patients with facial nerve palsy and lagophthalmus.	Device: NEURO-BLINK Device; The NEURO-BLINK is a class IIa medical device that intends to restore the blink function in patients with facial palsy through the application of transcutaneous electrical stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
External electrical stimulation for a painless eye closure - Percentage of Eye closure (Parameter 1)	The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators aim to measure: Percentage of Eye closure during blink (between supported condition and pathological condition)	2 year
External electrical stimulation for a painless eye closure - Percentage of cornea coverage during blink (Parameter 2)	The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, we measure: Percentage of cornea coverage during blink (between supported condition and pathological condition) measured in mm	2 year
External electrical stimulation for a painless eye closure - Lagophthalmos reduction in mm (Parameter 3)	The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: Lagophthalmos reduction during closed eyes (between supported condition and pathological condition) measured in mm	2 year
External electrical stimulation for a painless eye closure - Visual acuity (Parameter 4)	The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: Visual acuity before and after the treatment through electronic Snellen charts	2 year
External electrical stimulation for a painless eye closure - influence upon corneal eye dryness (Parameter 5)	The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: eye dryness before and after the treatment through Oxford scale	2 year
External electrical stimulation for a painless eye closure - influence upon quality of life in reference to eye dryness (Parameter 6)	The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: dry eye questionnaire through OSDI and McGill quality of life	2 year

Collaborators and Investigators

• Sponsor: Kantonsspital Aarau
• Collaborators: ETH Zurich
• Investigators: Study Chair: Marcel Menke, Cantonal Hospital Aarau Ophthalmology Department

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: neurostimulation; orbicularis oculi
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Bell Palsy; Facial Paralysis; Facies; Facial Nerve Diseases
• Other Study ID Numbers: NB01

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: No