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

NCT06069128 | Completed

• 1 other identifier: CLN 0100
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Paralysis; Paralysis; Eye; Paralysis; Bell

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  14 days treatment

Study Arms (1)

Neurotrigger device treatment arm

EXPERIMENTAL

treatment with Neuro-trigger device for blinking stimulation for a duration of 14 days

Device: Neurotrigger Basic. eye blinking stimulator

Interventions

Neurotrigger Basic. eye blinking stimulator DEVICE

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

Neurotrigger device treatment arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurotrigger Ltd: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Paralysis; Bell Palsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases

Study Officials

• Daniel Keidar, Dr

  Tel Aviv sourasky medical center ichilov

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 5, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IL (1)