Artificial Eye Blinking Stimulation Following Paralysis of the Facial Nerve (Bioniceye)
Facial Paralysis, Bell Palsy
About this trial
This is an interventional treatment trial for Facial Paralysis focused on measuring Eye blinking, facial nerve paralysis, nano electrode
Eligibility Criteria
Inclusion Criteria:
- 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:
5. 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:
5. 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
- All initial inclusion criteria will be as in phase 1
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tel Aviv Sourasky Medical Center (Ichilov)
Arms of the Study
Arm 1
Other
Single use and continuous use
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.