The Effect of neuromuscular electrical stimulation (NMS) and botulinum neurotoxin on facial movement disorders
- Conditions
- G24.5G51.3BlepharospasmClonic 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
– 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
– 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
Name Time Method 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
Name Time Method 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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