Facial Nerve PalsyNEURO-BLINKNCT05504473
Blink Restoration in Patients With Facial Nerve Palsy
A study testing NEURO-BLINK Device in people with Facial Nerve Palsy, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
This study is a non-blinded single armed pilot study aiming to apply a newly created medical device in patients with seventh nerve palsy suffering from lagophthalmus in order to determine the best way for neuromuscular stimulation of the orbicularis oculi muscle and facial nerve in order to enable eyelid closure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Nerve Palsy
- What is being tested?
- NEURO-BLINK Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2022to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Facial palsy
- Lagophthalmus
Who cannot join
- Minors
- Pacemaker or defibrillator
- Vulnerable population
- Patients in emergency situations
- Allergies on the sticky electrodes and MD metallic sensors
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ophthalmology Department Cantonal Hospital Aarau
Aarau, Canton of Aargau, 5001
About this study
This study is a non-blinded single armed pilot study aiming to apply a newly created medical device in patients with seventh nerve palsy suffering from lagophthalmus in order to determine the best way for neuromuscular stimulation of the orbicularis oculi muscle and facial nerve in order to enable eyelid closure (blink). Initially, a tailored external neurostimulation prototype will be created in collaboration with the ETH for patients with facial nerve palsy and lagophthalmos. Aim of this study is to create an efficient, safe and comfortable medical device that can achieve an effective blinking through external electrical neuromuscular stimulation of the orbicularis oculi in patients with facial palsy and lagophthalmos. Such a device can become an essential part of facial palsy treatment.
Read the detailed description
Facial paralysis rates are reported to be 4/10,000 per annum leading to facial asymmetry and impairs essential facial functions, including blinking, protection of the cornea, lip competence, mastication, speaking, but also has psychosocial penalties.
Facial animation is orchestrated by the facial muscles directed by the facial nucleus through a network of the facial nerve and its branches. The facial nerve (CNVII) plays a critical role in multiple complex functions of human life including mastication, speech, and successful social communication through expression of mood and emotion. The absence of facial nerve's function can be a result of a developmental anomaly, of a stroke leading to a damage to the central segment of this nerve (facial nucleus in the pons, motor cortex, or connections between the two), an iatrogenic or traumatic injury, a neoplastic infiltration or an infectious (e.g., borreliosis and herpes zoster), or idiopathic inflammation of the extratemporal segments of the facial nerve. The peripheral facial paralysis (PFP), resulting from affection of the seventh nerve is the most common pathology of the cranial pairs.
The facial nerve normally emits electrical impulses to give muscles their tone and shape. Therefore, when it is damaged, the muscles become weak and floppy. External electrical stimulation can mimic the electrical nerve impulses and help restore muscle tone in patients with facial palsy. Applications involving nerve stimulation can be divided into three separate categories: therapeutic electrical stimulation (TES), neuromodulatory stimulation (NMS), and functional electrical stimulation (FES). By FES standards, neural prosthetic reanimation of the eyelids for blink restoration is a relatively simple and low-risk application. Restoration of blinking involves a single muscle, the orbicularis oculi. The presence of the nerve is not required for external electrical stimulation to be used.
External electrical neuromuscular stimulation can try to mimic the electrical nerve impulses in patients with facial palsy. However, no device has yet been proven appropriate for daily use. The research question the investigators aim to answer is whether an efficient, safe and comfortable medical device that can achieve an effective blinking through external electrical neuromuscular stimulation of the orbicularis oculi in patients with facial palsy and lagophthalmos can be created. The stimulation will be provided in the form of charge balanced biphasic square pulses as shown in the image below at a frequency of 100Hz. The investigators mainly want to determine the functionality of a constant external electrostimulation for the patients. Blinking sufficiency will be evaluated qualitatively and quantitatively through surveys and observations.
The investigators aim to recruit initially 10 patients suffering from lagophthalmos due to facial nerve palsy, who will be invited to wear the device. The exact parameters needed for the neurostimulation and symptoms of patients or any adverse events will be documented on the case report form (CRF).
- Conditions
- Facial Nerve Palsy
- Being tested
- NEURO-BLINK Device
- Keywords
- neurostimulation, orbicularis oculi
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURO-BLINK DeviceDevice
The NEURO-BLINK is a class IIa medical device that intends to restore the blink function in patients with facial palsy through the application of transcutaneous electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with facial nerve palsy and lagophthalmus | Experimental | There is only one arm in this study. The investigators examine if the medical device can achieve a painless blinking in patients with facial nerve palsy and lagophthalmus. Receives: Device: NEURO-BLINK Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
External electrical stimulation for a painless eye closure - Percentage of Eye closure (Parameter 1)
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators aim to measure: Percentage of Eye closure during blink (between supported condition and pathological condition)
Measured: 2 year
External electrical stimulation for a painless eye closure - Percentage of cornea coverage during blink (Parameter 2)
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, we measure: Percentage of cornea coverage during blink (between supported condition and pathological condition) measured in mm
Measured: 2 year
External electrical stimulation for a painless eye closure - Lagophthalmos reduction in mm (Parameter 3)
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: Lagophthalmos reduction during closed eyes (between supported condition and pathological condition) measured in mm
Measured: 2 year
External electrical stimulation for a painless eye closure - Visual acuity (Parameter 4)
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: Visual acuity before and after the treatment through electronic Snellen charts
Measured: 2 year
External electrical stimulation for a painless eye closure - influence upon corneal eye dryness (Parameter 5)
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: eye dryness before and after the treatment through Oxford scale
Measured: 2 year
External electrical stimulation for a painless eye closure - influence upon quality of life in reference to eye dryness (Parameter 6)
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: dry eye questionnaire through OSDI and McGill quality of life
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start31 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Nerve PalsyStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Principal investigator, Anthia Papazoglou, Kantonsspital Aarau
- Investigators
- Marcel Menke, Study chair, Cantonal Hospital Aarau Ophthalmology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504473
- Sponsor's protocol ID
- NB01
- Acronym
- NEURO-BLINK
- Status last verified
- Mar 2024
- First submitted
- 30 Oct 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blink Restoration in Patients With Facial Nerve Palsy
- ClinicalTrials.gov ID
- NCT05504473
- Acronym / sponsor ID
- NEURO-BLINK / NB01
- Conditions
- Facial Nerve Palsy
- Keywords
- neurostimulation, orbicularis oculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Aug 2022 (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 study is a non-blinded single armed pilot study aiming to apply a newly created medical device in patients with seventh nerve palsy suffering from lagophthalmus in order to determine the best way for neuromuscular stimulation of the orbicularis oculi muscle and facial nerve in order to enable eyelid closure (blink). Initially, a tailored external neurostimulation prototype will be created in collaboration with the ETH for patients with facial nerve palsy and lagophthalmos. Aim of this study is to create an efficient, safe and comfortable medical device that can achieve an effective blinking through external electrical neuromuscular stimulation of the orbicularis oculi in patients with facial palsy and lagophthalmos. Such a device can become an essential part of facial palsy treatment.
Detailed description
Facial paralysis rates are reported to be 4/10,000 per annum leading to facial asymmetry and impairs essential facial functions, including blinking, protection of the cornea, lip competence, mastication, speaking, but also has psychosocial penalties.
Facial animation is orchestrated by the facial muscles directed by the facial nucleus through a network of the facial nerve and its branches. The facial nerve (CNVII) plays a critical role in multiple complex functions of human life including mastication, speech, and successful social communication through expression of mood and emotion. The absence of facial nerve's function can be a result of a developmental anomaly, of a stroke leading to a damage to the central segment of this nerve (facial nucleus in the pons, motor cortex, or connections between the two), an iatrogenic or traumatic injury, a neoplastic infiltration or an infectious (e.g., borreliosis and herpes zoster), or idiopathic inflammation of the extratemporal segments of the facial nerve. The peripheral facial paralysis (PFP), resulting from affection of the seventh nerve is the most common pathology of the cranial pairs.
The facial nerve normally emits electrical impulses to give muscles their tone and shape. Therefore, when it is damaged, the muscles become weak and floppy. External electrical stimulation can mimic the electrical nerve impulses and help restore muscle tone in patients with facial palsy. Applications involving nerve stimulation can be divided into three separate categories: therapeutic electrical stimulation (TES), neuromodulatory stimulation (NMS), and functional electrical stimulation (FES). By FES standards, neural prosthetic reanimation of the eyelids for blink restoration is a relatively simple and low-risk application. Restoration of blinking involves a single muscle, the orbicularis oculi. The presence of the nerve is not required for external electrical stimulation to be used.
External electrical neuromuscular stimulation can try to mimic the electrical nerve impulses in patients with facial palsy. However, no device has yet been proven appropriate for daily use. The research question the investigators aim to answer is whether an efficient, safe and comfortable medical device that can achieve an effective blinking through external electrical neuromuscular stimulation of the orbicularis oculi in patients with facial palsy and lagophthalmos can be created. The stimulation will be provided in the form of charge balanced biphasic square pulses as shown in the image below at a frequency of 100Hz. The investigators mainly want to determine the functionality of a constant external electrostimulation for the patients. Blinking sufficiency will be evaluated qualitatively and quantitatively through surveys and observations.
The investigators aim to recruit initially 10 patients suffering from lagophthalmos due to facial nerve palsy, who will be invited to wear the device. The exact parameters needed for the neurostimulation and symptoms of patients or any adverse events will be documented on the case report form (CRF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with facial nerve palsy and lagophthalmus | Experimental | Device: NEURO-BLINK DeviceThere is only one arm in this study. The investigators examine if the medical device can achieve a painless blinking in patients with facial nerve palsy and lagophthalmus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- Facial palsy
- Lagophthalmus
Key exclusion criteria (5 listed)
- Minors
- Pacemaker or defibrillator
- Vulnerable population
- Patients in emergency situations
- Allergies on the sticky electrodes and MD metallic sensors
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 |
|---|---|---|
| NEURO-BLINK DeviceThe NEURO-BLINK is a class IIa medical device that intends to restore the blink function in patients with facial palsy through the application of transcutaneous electrical stimulation. | Device | Patients with facial nerve palsy and lagophthalmus |
Primary outcome
External electrical stimulation for a painless eye closure - Percentage of Eye closure (Parameter 1)
Time frame: 2 year
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators aim to measure: Percentage of Eye closure during blink (between supported condition and pathological condition)
External electrical stimulation for a painless eye closure - Percentage of cornea coverage during blink (Parameter 2)
Time frame: 2 year
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, we measure: Percentage of cornea coverage during blink (between supported condition and pathological condition) measured in mm
External electrical stimulation for a painless eye closure - Lagophthalmos reduction in mm (Parameter 3)
Time frame: 2 year
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: Lagophthalmos reduction during closed eyes (between supported condition and pathological condition) measured in mm
External electrical stimulation for a painless eye closure - Visual acuity (Parameter 4)
Time frame: 2 year
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: Visual acuity before and after the treatment through electronic Snellen charts
External electrical stimulation for a painless eye closure - influence upon corneal eye dryness (Parameter 5)
Time frame: 2 year
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: eye dryness before and after the treatment through Oxford scale
External electrical stimulation for a painless eye closure - influence upon quality of life in reference to eye dryness (Parameter 6)
Time frame: 2 year
The investigators aim to use external electrical neuromuscular stimulation in order to achieve eye blinking/closure in 10 patients with lagophthalmos due to facial nerve palsy. In particular, the inverstigators measure: dry eye questionnaire through OSDI and McGill quality of life
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 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Facial Nerve Palsy
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
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.
Marcel Menke study chair
Cantonal Hospital Aarau Ophthalmology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEURO-BLINK Device in people with Facial Nerve Palsy, run by Kantonsspital Aarau at 1 site in Switzerland.
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 3 inclusion and 5 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 12 Mar 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 Switzerland. 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?
External electrical stimulation for a painless eye closure - Percentage of Eye closure (Parameter 1) (time frame: 2 year). The study lists 6 primary outcomes in all. 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 12 Mar 2024.