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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033413
Enrollment
40
Registered
2024-01-18
Start date
2024-02-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G24.5 G51.3

Interventions

Group 1: Motoric NMS with a frequency of 30 - 99 Hz, the amplitude is adjusted until visible muscle contractions are achieved. In the first visit (V1
one week before the next BoNT injection), only motoric NMS is carried out to demonstrate the effectiveness of NMS without BoNT. From the second visit (V2-V5), NMS in addition to BoNT therapy to demons

Sponsors

Klinik für Neurologie, Universitätsklinikum Jena
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
The primary study goals are improved patient satisfaction and reduced subjective disease severity. Questionnaires: SF-36, WHOQOL, BFI, PHG-9, GAS

Secondary

MeasureTime 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

Public ContactJulia Schubert

Klinik für Neurologie, Universitätsklinikum Jena

julia. schubert@med.uni-jena.de00493641-9323543

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026