Status:
COMPLETED
Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve.
Lead Sponsor:
Neurotrigger Ltd
Conditions:
Paralysis
Paralysis; Eye
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
This is a single-center, open-label clinical study. Up to 11 subjects will be enrolled to use the Neuro-trigger device for blinking stimulation for a duration of 14 days.
Detailed Description
Facial paralysis is a well-known and severe condition. The paralysis can be permanent or temporary, depending on the cause and on the severity. It usually affects only one side of the patient's face, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06069128
Start Date
October 1 2023
End Date
September 5 2024
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tel Aviv Sourasky Medical Center (Ichilov)
Tel Aviv, Israel