Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve. — paralysis  

Paralysis Clinical Trial

Official title: A Single Center, Open Label, Pilot Study to Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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, and so it makes the affected side of the face look like it is drooping.

The two facial nerves control each the muscles on one side of the face. A damaged facial nerve distal to the impaired area is dead and is unable to carry messages from the brain to the facial respective muscles either completely or partially, depending on the level of damage. This leads to muscle weakness, twitching or paralysis. In addition, damage to the nerve can cause the eyelid to drop, and the angle of the patient's mouth can also be twisted, usually towards down. In some cases of bell's Palsy, the nerve is capable to regenerate into the tunnel where it run before, and some studies have shown that stimulation may facilitate the growth toward the desired direction.

Under normal circumstances, the human eye blinks every 2-10 seconds. With every blink the eyelid spreads moisture over the cornea. With facial paralysis the ability to blink may be impaired or absent all together.The dry eye syndrome gets exacerbated since damage to the facial nerve also impairs the signal to the tear gland to generate tears, which mean that the production and secretion of tears in the affected eye is impaired.

With no effective treatment so far, and as paralysis persists, the severity of secondary damage to the eye increases including irritation of the eye (conjunctivitis), ulceration of the cornea, and it might cause severe disability and even blindness.

All the treatment options currently offered in the cases described above are partial and insufficient, and are aimed at alleviating symptoms and providing relief only.

The current treatment options are:

1. Application of eye drops (artificial tears), gel and\or ointment

2. Tarsorrhaphy is the surgical fusion of the upper and lower eyelid margins.

3. Eyelid gold weight insertion.

4. A punctual plug.

Most of the existing treatment options deal with the symptoms of the dry eye syndrome, such as blurred vision, while the solution proposed by us is designed to address the original cause of the problem - the loss of eye muscle blinking due to loss of nerve stimulus due to the injury of the facial nerve.

The Neurotrigger device offers a comprehensive treatment system mainly designed for cases of functional impairment of the eye due to facial paralysis.

People with facial nerve paralysis cannot blink and cannot close the affected eye, day or night. As a result, the patients suffer from short and long-term consequences, including pain, discomfort, dry eye syndrome, and possible graduate impairment of vision.

Therefore, we suggest a novel daytime stimulating device based on an electrical stimulation of the facial nerve designed to restore blinking. This device is estimated to advance/improve/create a breakthrough in the current available treatment for rehabilitation of the affected eye in cases of facial nerve paralysis.

We recommend using this novel daytime system in combination with a specific solution for nighttime, designed to mechanically maintain the eye closed at night.

The day and night component of the solution have each separately its specific merits yet combining both solutions, creates a comprehensive treatment that may bring clear improvement for the patient.

The Neurotrigger device aims to restore eye blinking during the day based on electrical stimulation that is carried by the underlying injured nerve to activate the respective muscle unit and renew eye blinking and tear release. ;

Related Conditions & MeSH terms

• Paralysis

• NCT number: NCT06069128
• Study type: Interventional
• Source: Neurotrigger Ltd
• Contact: Hila Kfir, b.sc
• Phone: 972-523313350
• Email: hilaz28@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Completion date: April 1, 2024