Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve.
Sponsored by Neurotrigger Ltd
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Male or female subjects above 18 years of age
- Subject whom able to provide a written informed consent.
- Subjects who are willing to provide medical and demographic records of their facial paralysis, the consequences of the paralysis and general medical history.
- Patients who answer the full definition of continuous existing unilateral facial paralysis.
- Patients who comply with the definition of unilateral facial paralysis up to 12 months from the first diagnosis.
- Enrolment will depend on the subject's willingness and capability to perform the daily treatment with the use of the Neuro-trigger simulator (including operating the device and electrode placement ) for a duration of 2 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.
- Patients who underwent an operation for facial reanimation at least one year prior to enrollment
- Patients whom are currently participating in other clinical study
- High probability of orbicularis oculi atrophy or damage (i.e. long-standing facial paralysis or cases
- History of ablative surgery where the musculature has been sacrificed)
- History of prior facial reanimation procedures
- History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe
- cognitive or motor impairment, severe immunological deficiency, and malignant diseases that are not in remission
- Signs of corneal infection or severe ocular surface inflammation
- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device