G24.5 G51.3
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: – Patients with facial movement disorders, regardless of whether symptoms have improved from previous botulinum toxin injections – The effects of previous treatments, including but not limited to botulinum toxin injection, must have completely resolved at the time of inclusion – Signed and dated consent form from the study participant before carrying out study-specific measures
Exclusion criteria
Exclusion criteria: – Lack of compliance with the inclusion criteria – Patients suffering from neurodegenerative diseases – Severe depression, i.e. = 20 according to the Beck Depression Inventory (BDI) – Mental or psychiatric illnesses – Pregnant or breastfeeding women – Carrier of an active medical implant – Known allergies or intolerances to materials used in this study – Concurrent participation in other drug or medical device studies that could affect the results of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study goals are improved patient satisfaction and reduced subjective disease severity. Questionnaires: SF-36, WHOQOL, BFI, PHG-9, GAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary goals are to demonstrate the effectiveness of neuromuscular electrical stimulation, reduce the BoNT-dose and extend the symptom-free phases. disease-specific questionnaires: - Hemifacial spasm / blepharospasm: CDQ-24, UDRS, DNMS-Quest, BSS, BSDI, JRS - Synkinesia after peripheral facial paralysis: FaCE, FDI, SAQ | — |
Countries
Germany
Contacts
Klinik für Neurologie, Universitätsklinikum Jena