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The Effect of neuromuscular electrical stimulation (NMS) and botulinum neurotoxin on facial movement disorders

Not Applicable
Conditions
G24.5
G51.3
Blepharospasm
Clonic hemifacial spasm
Registration Number
DRKS00033413
Lead Sponsor
Klinik für Neurologie, Universitätsklinikum Jena
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
40
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

– 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary study goals are improved patient satisfaction and reduced subjective disease severity.<br>Questionnaires: SF-36, WHOQOL, BFI, PHG-9, GAS
Secondary Outcome Measures
NameTimeMethod
Secondary goals are to demonstrate the effectiveness of neuromuscular electrical stimulation, reduce the BoNT-dose and extend the symptom-free phases.<br>disease-specific questionnaires:<br>- Hemifacial spasm / blepharospasm: CDQ-24, UDRS, DNMS-Quest, BSS, BSDI, JRS <br>- Synkinesia after peripheral facial paralysis: FaCE, FDI, SAQ
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