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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04153916
Other study ID # 0266-19-TLV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date November 1, 2021

Study information

Verified date September 2021
Source Neurotrigger Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Neurotrigger eye blinking stimulator
Phase 1 - The first stage is composed of a one-time participation for about three hours and involves: Verifying compliance of the patients with the research inclusion and exclusion criteria Completion of the study clinical report form (CRF) for this stage 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

Locations

Country Name City State
Israel Tel Aviv Sourasky Medical Center (Ichilov) Tel Aviv

Sponsors (2)

Lead Sponsor Collaborator
Neurotrigger Ltd Tel Aviv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Stage 2 only - Improving quality of life - The measurement will be performed by filling out a Quality of Life Questionnaire. Reducing dry eye effects. Dry eye effects will be measured by filling out a Quality of Life Questionnaire including questioning about the frequency of use of eye drops. three weeks
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