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:
The study will involve two groups:
Group 1: 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.
Group 2: 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.
After being identified eligible to participate in the study, the patients will be invited to
join the study, sign on the written informed consent, and their demographic and medical
history will be recorded.
Patients identified to belong to these study groups in other hospitals may join the study,
after pre-evaluation and medical record analysis by the study Principle Investigator
(PI)/Co-PI.
The study will be constructed in two phases:
Phase 1 - The first stage is composed of a one-time participation for about three hours. This
feasibility stage 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.
An initial report will then be issued to summarize the patient's experience of using the
system in the first testing attempt to identify a complete or partial eye blinking.
Participants identified to respond to the stimulator at a partial or complete eye closure
level, will be invited to continue to use the device for additional two hours in the hospital
premises.
A summary meeting will then be held to issue a summary report covering the overall patient's
experience of using the system throughout the testing period.
The purpose of this first stage is to examine the possibility of closing the patient eyelid
completely or partially, optimize electrode position, and maximize the patient's comfort
level.
A profile of system efficacy in generating eyelid closure will then be generated including
the characterization of the stimulus pattern (intensity, frequency, etc.)
Phase 2: The purpose of this stage is to examine how a continued use of the device by the
patient may improve outcomes, and reduce complications that are derived of the facial nerve
paralysis
Participants may be enrolled to the second phase up to one year from the first phase visit
In this 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.
The patient and the partner will both obtain a detailed mutual training of placing the
electrode and device, activating the device (partner) and its use (patient) to assure
complete assistance and guidance in installing the system and its use.
Prior to starting this stage the patient will undergo eye examination and will complete a
Patient Graded Instrument for Facial Nerve Paralysis - The FaCE Scale Questionnaire - to
evaluate the life quality with the facial nerve paralysis (Laryngoscope. 2001
Mar;111(3):387-98.Validation of a patient-graded instrument for facial nerve paralysis: the
FaCE scale. Kahn JB et al.)
Patients are provided with help desk number to answer questions and queries during the study
period as needed.
They will get a clear guidance of the possibility to get support at home by experience system
user or by phone-call or by videoconference (Skype or the like) by communicating with the
experienced Sponsor's personnel who can help them adjust the electrode to the face and
reducing discomfort.
In case of a skin rush or any skin discomfort, the patient will call the clinic and will be
invited to medical examination and, if necessary, for treatment of a rush reducing and
calming ointment and be advised of re-using the system.
Participants will make an intermediate evaluation at one and a half week and a final visit at
three weeks.
The last visit will include eye examination to compare the eye functioning before and after
Phase 2, and the completion of a FaCE Scale Questionnaire to evaluate potential improvement
in life quality.
