Evaluation of the response of the target muscle to direct electrostimulation and/or electrostimulation of the innervating portion of the facial nerve in patients suffering from facial palsy

Not Applicable

• Conditions: G51.0; Bell palsy

• Registration Number: DRKS00015015
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

The preliminary results of this clinical investigation showed that a selective ZYG response can be safely conducted with needle or ball electrodes in awaken patients or intraoperatively, respectively. The study showed that the intraoperative assessment did not ensure additional benefits compared to the needle stimulation in awaken patients. In particular, the awake setting did not cause discomfort or pain to the patients. Intra-operative stimulation: The results obtained with intra-operative stimulation showed the need to improve the technique in order to ensure reproducible and successful response of the MOO and ZYG. Stimulation in awaken patients: The results of the stimulation conducted in awaken patients showed that at least the ZYG can be selectively stimulated and that percutaneous muscle stimulation can be successfully conducted with shorter PW (= 5 ms vs. = 60 ms) and with an amplitude = 4 mA. In this study, only patients with complete ZYG paralysis were assessed. Due to the exploratory nature of this study, the lack of a possibility to be easily and quickly translated to a clinically relevant diagnostic method, and issues linked to the COVID-19 pandemic it was decided to conclude the recruitment.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-28
• Study Completion: 2022-04-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Age = 18
- Suffering from facial palsy, including facial paresis, paralysis and synkinetic
- For intra-operative stimulation only: Pre-scheduled for an ENT surgery for which portions of the facial nerve and/or muscles innervated by the facial nerve are exposed
- Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation
- High motivation with realistic expectations regarding the participation in this clinical investigation
- Signed and dated informed consent before the start of any study specific assessment.

Exclusion Criteria

- Lack of compliance with any inclusion criteria
- Pregnant or breast-feeding women
- Other clinical diseases that might result in alteration of the outcomes of this clinical investigation, in particular muscular diseases
- Use of an active implant
- Known allergies or intolerance to the material used for this clinical investigation
- Current participation in other drugs and/or medical device studies that can affect the results of the present clinical investigation
- Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- The target of the stimulation (nerve vs. muscle)<br>- The specificity of the response of the various facial muscle depending on their facial palsy grade<br>- The stimulation setting (on awaken vs. anesthetized patients)<br>

Secondary Outcome Measures

Name	Time	Method
- Facial palsy etiology<br>- Facial palsy duration<br>- Age and gender of the patients<br>