Blink Restoration in Patients With Facial Nerve Palsy

NCT05504473 | Completed DMC

• 1 other identifier: NB01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Nerve Palsy

Keywords

neurostimulation; orbicularis oculi

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Patients with facial nerve palsy and lagophthalmus

EXPERIMENTAL

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

Interventions

NEURO-BLINK Device 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.

Patients with facial nerve palsy and lagophthalmus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Facial palsy
• Lagophthalmus

You may not qualify if:

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

Sponsors & Collaborators

• Kantonsspital Aarau: lead
• ETH Zurich: collaborator

Study Sites (1)

Ophthalmology Department Cantonal Hospital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Marcel Menke

  Cantonal Hospital Aarau Ophthalmology Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: August 17, 2022
• Study Start: March 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)