Blink Restoration in Patients With Facial Nerve Palsy
NCT05504473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-03-12
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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