The study of the new medical device for blink restoration in patients with facial nerve palsy
Kantonsspital Aarau is starting a new clinical trial of Blink Restoration in Patients With Facial Nerve Palsy.
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.
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.
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).
The clinical trial started in May 1, 2022 and will continue throughout October 31, 2024.
For more details: https://ichgcp.net/clinical-trials-registry/NCT05504473.
