ParalysisparalysisNCT06069128
Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve.
A study testing Neurotrigger Basic. eye blinking stimulator in people with Paralysis and Paralysis; Eye, run by Neurotrigger Ltd at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Paralysis, Paralysis; Eye, Paralysis; Bell
- What is being tested?
- Neurotrigger Basic. eye blinking stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2023to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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, 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:
- Application of eye drops (artificial tears), gel and\or ointment
- Tarsorrhaphy is the surgical fusion of the upper and lower eyelid margins.
- Eyelid gold weight insertion.
- 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.
- Conditions
- Paralysis, Paralysis; Eye, Paralysis; Bell
- Being tested
- Neurotrigger Basic. eye blinking stimulator
- Medical subject headings
- Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotrigger Basic. eye blinking stimulatorDevice
Also called NTB-KT-0003
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurotrigger device treatment arm | Experimental | treatment with Neuro-trigger device for blinking stimulation for a duration of 14 days Receives: Device: Neurotrigger Basic. eye blinking stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days treatment
Secondary outcomes (1)
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.
Measured: 14 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Aug 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotrigger Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Keidar, Dr, Principal investigator, Tel Aviv sourasky medical center ichilov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069128
- Sponsor's protocol ID
- CLN 0100
- Acronym
- paralysis
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06069128
- Acronym / sponsor ID
- paralysis / CLN 0100
- Conditions
- Paralysis, Paralysis; Eye, Paralysis; Bell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Neurotrigger LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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:
- Application of eye drops (artificial tears), gel and\or ointment
- Tarsorrhaphy is the surgical fusion of the upper and lower eyelid margins.
- Eyelid gold weight insertion.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neurotrigger device treatment arm | Experimental | Device: Neurotrigger Basic. eye blinking stimulatortreatment with Neuro-trigger device for blinking stimulation for a duration of 14 days |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurotrigger Basic. eye blinking stimulatorAlso: NTB-KT-0003NeuroTrigger 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. | Device | Neurotrigger device treatment arm |
Primary outcome
To evaluate the Neuro-trigger device usability in the treatment of unilateral facial paralysis subjects.
Time frame: 14 days treatment
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
1 secondary outcome
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.
Time frame: 14 days treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Keidar, Dr principal investigator
Tel Aviv sourasky medical center ichilov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotrigger Basic. eye blinking stimulator in people with Paralysis and Paralysis; Eye, run by Neurotrigger Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the Neuro-trigger device usability in the treatment of unilateral facial paralysis subjects. (time frame: 14 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.