Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve

NCT04153916 | Completed

• 1 other identifier: 0266-19-TLV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Eye blinking, facial nerve paralysis, nano electrode

Outcome Measures

Primary Outcomes (1)

• Eyelid closure - Partial or complete closure

  Partial or complete eye closure. The results will be detailed in a data table which will include details of the number of participants, affiliation to a research group and level of eyelid closure.

  3 hours

Secondary Outcomes (1)

• Stage 2 only - Improving quality of life - The measurement will be performed by filling out a Quality of Life Questionnaire.

  three weeks

Study Arms (1)

Single use and continuous use

OTHER

Patients with a continuous unilateral facial paralysis that underwent an operation for facial reanimation will be enrolled at least one year after the operation according to review of medical records of the Department of plastic surgery. Patients with temporary unilateral facial paralysis secondary to Bell's palsy as was identified in the admission to the Hospital Department of Plastic Surgery or to the Department of Ear, Nose and Throat.

Device: Neurotrigger eye blinking stimulator

Interventions

Neurotrigger eye blinking stimulator DEVICE

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

Single use and continuous use

Eligibility Criteria

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

You may qualify if:

• Patients who meet ALL of the following criteria will be eligible for enrollment into this study:
• All patients
• Male or female above 18 years of age inclusive
• All patients will have to agree to provide a written informed consent, Fully understand all elements of and actually sign and date the written Institutional Review Board (IRB) approved informed consent before initiation of protocol-specified procedures;
• Willing to provide medical and demographic records of their facial paralysis, the consequences of the paralysis and general medical history.
• Group 1:
• \. Patients who comply with the definition of continuous existing unilateral facial paralysis and who underwent an operation for facial reanimation at least one year prior to enrollment
• Group 2:
• \. Patients who comply with the definition of temporary unilateral facial paralysis secondary to Bell's palsy up to 2 years from the event.
• Second Phase
• Enrollment will be dependent on having a partner willing and capable to offer the six days a week daily support in placing the Neurotrigger simulator and closing eye at night time for a period of 3 weeks.

You may not qualify if:

• Patients with chronic facial paralysis and secondary established damage to the eye occurring prior to enrollment, Who did not undergo facial reanimation surgery.
• Patients with psychiatric, addictive, or any other disorder that compromises ability to give genuine informed consent for participation in this study.
• Patients suffering from any skin condition that will prevent effective attachment of the electrodes, including but not limited to allergy to any of the components of the skin electrode.
• Woman who is pregnant (positive pregnancy test)
• Woman who is nursing
• Unwillingness or inability to follow the procedures outlined in the protocol.

Sponsors & Collaborators

• Neurotrigger Ltd: lead
• Tel Aviv Medical Center: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Facial Paralysis; Bell Palsy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Facial Nerve Diseases; Cranial Nerve Diseases

Study Officials

• Eyal Gur, MD

  Chairman, Dep. Plastic Surgery, Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Principle Investigators of the Clinical study will code the patients by the study enrolment number provided at the day of enrolment and is not disclosed to the sponsor
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: elicit a complete or a partial eyelid closure \& 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.

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: November 6, 2019
• Study Start: August 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: November 1, 2021
• Last Updated: March 21, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)