Informations générales
  • Catégorie de maladie Maladies de l'œil , Maladies du système nerveux (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Aarau
    (BASEC)
  • Responsable de l'étude Anthia Papazoglou anthia.papazoglou@gmail.com (BASEC)
  • Source(s) de données BASEC: Importé de 16.10.2025 ICTRP: N/A
  • Date de mise à jour 16.10.2025 09:25
HumRes67391 | SNCTP000006629 | BASEC2025-D0071

NEURO-BLINK V2 against Lagophthalmos in Facial Paralysis

  • Catégorie de maladie Maladies de l'œil , Maladies du système nerveux (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Aarau
    (BASEC)
  • Responsable de l'étude Anthia Papazoglou anthia.papazoglou@gmail.com (BASEC)
  • Source(s) de données BASEC: Importé de 16.10.2025 ICTRP: N/A
  • Date de mise à jour 16.10.2025 09:25

Résumé de l'étude

Facial paralysis can arise from various causes such as strokes, accidents, or surgeries, often leading to the inability of affected individuals to close their eyes properly. This can not only impair vision and eye health but also affect the emotional well-being of patients, as they often feel insecure due to the visible imbalance in their face. In our project, we investigate how reading the muscle function of the healthy side of the face can generate a symmetrical movement on the paralyzed side by applying electrical stimulation to the muscle around the eye. The goal is to better protect the patients' eyes while simultaneously improving their quality of life. The treatment is based on a safe, non-invasive method. A pair of glasses is worn that conceals cables and skin adhesives. The glasses are intended to be worn for several hours a day to document the advantage of improved eye lubrication and to enable an improvement in quality of life – by reducing the need for patients to use lubricants, becoming less dependent on eye patches, and appearing more aesthetically discreet. Additionally, we want to find out whether certain factors, such as the cause of the paralysis or the duration of the condition, influence the success of the treatment. The long-term goal is to develop an effective and portable solution that helps patients ease their daily lives.

(BASEC)

Intervention étudiée

After obtaining the patient's consent to participate in the study, a comprehensive survey is first conducted. This serves to gather important information about any pre-existing eye conditions, complaints, and the current treatment of facial paralysis.

 

The next step involves an ophthalmological examination, where vision is checked and the eyes are thoroughly examined to capture important parameters. These include the eyelid fissure (the distance between the upper and lower eyelids when the eye is open) and lagophthalmos (the distance between the upper and lower eyelids when the eye should be closed), the mobility of the eyelids, corneal exposure during eye closure, eye surface lubrication, and corneal health. These examinations are crucial to assess the condition of the eyes and establish a basis for further steps. All examinations are conducted at the eye clinic of the Cantonal Hospital Aarau (Building 60).

 

Subsequently, the external neurostimulation device developed by ETH is adjusted. When the device detects activity from the muscle element of the healthy side of the face, it immediately applies a fine electrical impulse through the skin to the nerve and muscle of the opposite paralyzed side. This impulse generates movement of the eyelids and closure on the paralyzed side, and the eye is lubricated. The intensity of the electrical impulses is individually adjusted to achieve maximum effect without causing discomfort. This allows for a personalized treatment tailored to the needs and sensitivities of the patients. Once the application of the device is completed, the previously conducted ophthalmological examinations are repeated to evaluate the effects of the treatment.

 

Multiple examination appointments can be scheduled. The goal is to understand how the neurostimulation device, the health of the eyes, and the quality of life of the patients can be improved. For this, the device must be worn long enough.

(BASEC)

Maladie en cours d'investigation

Facial paralysis (facial palsy) is a paralysis of the facial nerve that controls the muscles in the face. This nerve is important for us to express our face – for example, to smile, eat, blink, or close our eyelids. When the facial nerve is injured or damaged, one side of the face becomes stiff or asymmetrical, which often poses a significant burden for the affected individuals. Facial paralysis can arise from various causes, such as a stroke, injury, inflammation, or even after surgery. Depending on the cause, the chance of spontaneous recovery is low. People with facial paralysis often experience lagophthalmos. This term describes the problem where the eyelids can no longer be closed properly, leaving the eye inadequately protected. Normally, the eyelids close when blinking to protect the eyes from dust, dirt, and dryness. When this no longer works, symptoms such as dry eyes, irritation, and corneal injuries can occur. In severe cases, it can even lead to permanent damage to the cornea and, in the worst case, loss of vision or even the eye. Facial paralysis has not only physical but also emotional effects. Many affected individuals feel insecure about their altered appearance and often have to use eye drops multiple times a day or wear a bandage. If facial paralysis does not improve on its own after six months, there are surgical options to better protect the eye by narrowing the eyelid fissure. However, these surgeries do not restore the mobility of the eyelids or spontaneous blinking.

(BASEC)

Critères de participation
- Adults over 18 years - Unilateral facial paralysis with lagophthalmos (BASEC)

Critères d'exclusion
- Vulnerable individuals (BASEC)

Lieu de l’étude

Aarau

(BASEC)

non disponible

Sponsor

Kantonsspital Aarau

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Anthia Papazoglou

+41 62 838 50 04

anthia.papazoglou@gmail.com

Cantonal Hospital Aarau, Aarau, Aargau, Switzerland

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Date d'approbation du comité d'éthique

14.10.2025

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
Blink restoration in patients with facial nerve palsy V2 (NEURO-BLINK V2) (BASEC)

Titre académique
non disponible

Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

non disponible

Lien vers les résultats dans le registre primaire

non disponible