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Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve

NCT04153916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-21

No results posted yet for this study

Summary

Artificial eye blinking stimulation following damage to the facial nerve. Group 1 - Patients with a persistent unilateral facial paralysis (palsy) that underwent an operation for facial reanimation Group 2 - Patients with temporary unilateral facial paralysis, secondary to unilateral Bell's palsy.

Primary objective: To evaluate whether the Neurotigger device can elicit a complete or a partial eyelid closure of the affected eye.

Secondary objective: To optimize the location of the Neurotrigger's electrodes, and define the level of the pain generated, if any, during device implementation and stimulation, as well as the method for the personal adjustment of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients.

Conditions

  • Facial Paralysis
  • Bell Palsy

Interventions

DEVICE

Neurotrigger eye blinking stimulator

Phase 1 - The first stage is composed of a one-time participation for about three hours and involves: 1. Verifying compliance of the patients with the research inclusion and exclusion criteria 2. Completion of the study clinical report form (CRF) for this stage 3. Placement of the single use mini-electrodes that will be adhered to the facial skin near the non-blinking eye and coupled to the Neurotrigger stimulator to elicit eyelid closure. Participants may be enrolled to the second phase up to one year from the first phase visit In the second stage the duration of the participation is about three weeks (six days a week) and includes daily use of the device for up to 10 hours a day. During nights the patient will continue is standard pattern of either eye closure or leaving the eye open, as the patient used to do prior to the study. This stage will involve a patient with a partner that is designated to support the patient closely during the placement and adjustment of the system

Sponsors & Collaborators

  • Tel Aviv Medical Center

    collaborator OTHER

  • Neurotrigger Ltd

    lead INDUSTRY

Principal Investigators

  • Eyal Gur, MD · Chairman, Dep. Plastic Surgery, Tel Aviv Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-30
Completion
2021-11-01

Countries

  • Israel

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 NCT04153916 on ClinicalTrials.gov