Improvement of the severity of peripheral facial nerve palsy by surface electrical stimulation quantified with established and euclidean ratings

Not Applicable

• Conditions: G51.0; Bell palsy

• Registration Number: DRKS00026940
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Age = 18 years
- Diagnosed denervation of the zygomaticus on one side
- Anatomically and physiologically compatible with the criteria for participation in the clinical trial
- Mentally and physically able to use the external stimulator independently at home apply
- High motivation combined with realistic expectations regarding the Participation in the clinical trial.
- Signed and dated patient information and declaration of consent before carrying out any procedures relevant to the examination.

Exclusion Criteria

Lack of compliance with any inclusion criteria
- Pregnant or breastfeeding women
- Partial reinnervation of the zygomaticus muscle
- Any conservative treatment method (e.g. injections with botulinum toxin and / or wrinkle injection) in the face and head area or physical therapy measures to treat denervation of the zygomaticus muscle in the last 3 months prior to inclusion in this clinical trial
- Any prior surgical treatment for symptoms of denervation of the zygomaticus muscle
- Other clinical conditions affecting the results of this clinical trial could influence (general muscle diseases; epilepsy; skin diseases)
- Carrier of an active medical implant
- Known allergies or intolerances to materials used in used in clinical trials.
- Simultaneous participation in other drug or medical device studies, that could affect the results of this clinical trial
- Anything in the opinion of the investigator puts the patient at increased risk could expose, or compromise patient compliance could or what a successful completion of the clinical trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proof of an improvement in the muscle tone of the face based on the ratings and by measuring the photos

Secondary Outcome Measures

Name	Time	Method
Proof of reinnervation of the facial muscles based on the ratings and by measuring the photos