Blink Restoration in Patients With Facial Nerve Palsy

NCT05504473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ETH Zurich

    collaborator OTHER
  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Marcel Menke · Cantonal Hospital Aarau Ophthalmology Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504473 on ClinicalTrials.gov