An interventional study of Neurotrigger Basic. eye blinking stimulator in Paralysis, Paralysis; Eye and Paralysis; Bell, sponsored by Neurotrigger Ltd. Completed at 1 site in Israel. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Neurotrigger Ltd · Not applicable, Interventional, and Treatment
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.
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:
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.
147 studies on the registry are indexed under Paralysis; 40 are open to participants now.
This study's enrollment of 11 is below the median of 18 across 113 interventional studies indexed under Paralysis.
Browse Paralysis studies →Neurotrigger Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Paralysis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment with Neuro-trigger device for blinking stimulation for a duration of 14 days
Device: Neurotrigger Basic. eye blinking stimulator
NeuroTrigger Basic is intended to stimulate healthy muscles in order to improve or facilitate muscle performance for maintaining/increasing muscle range of motion and for the prevention or retardation of disuse atrophy.
Also known as: NTB-KT-0003
To evaluate the Neuro-trigger device usability in the treatment of unilateral facial paralysis subjects.
Examining the optimal location of placement for the Neuro- trigger's electrodes. * Establishing the level of pain generated if any, during device implementation and stimulation. * Exploring the personal adjustment process of the precise pattern of stimulation (strength, intensity, other features) to achieve eye blinking for different patients
Time frame: 14 days treatment
The secondary study objective is to evaluate the safety and effectiveness of the BlinkER in achieving eyelid closure during the study visits with facial nerve palsy.
* The number reported related of serious adverse events occurring throughout the study participation duration. * The number of reported related Adverse events occurring throughout the study participation duration.
Time frame: 14 days treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Aug 2024, 10 months.
Of 58 interventional studies with no phase under Paralysis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 133. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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