G24.3
Conditions
Interventions
Group 1: The approach evaluated in this clinical investigation is the unilateral percutaneous stimulation of the Ramus Musculii Trapezii by means of a needle or hooked-wire electrode. The stimulation
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 18 years - Patients diagnosed with focal, primary cervical dystonia: - In the shape of Torticollis, Laterocollis, Anterocollis, Retrocollis with or without neck rotation (rotatory torticollis or rotatocollis), lateral shift, or sagittal shift can be enrolled to this clinical investigation - Of idiopathic or genetic origin - Under successful botulin toxin treatment (i.e. they experienced a clinical benefit from previous botulin toxin injections within the last year) - Currently symptomatic because of the complete worn-off effects of the previous botulin toxin injection - Signed and dated informed consent before the start of any registry-specific procedure for all the recruited subjects
Exclusion criteria
Exclusion criteria: - Lack of compliance with any inclusion criteria - Primary CD with a neuroepilectic origin - Secondary CD following the establishment of neurodegenerative diseases - Suffering from depression equivalent to a score of = 20 according to the Beck Depression Inventory (BDI) - Suffering from psychological and or psychiatric diseases - Pregnant or breast-feeding women - Under anticoagulant treatment for the last 6 months (Phenprocoumon or similar) - DBS (Deep Brain Stimulation) users - Under anti-dystonia pharmacological treatments, ONLY if the treatment was changed within the last 12 months (stable anti-dystonia pharmacological treatment over the last 12 months is NOT an exclusion criterion) - Patients who underwent a previous CD surgery - Patients suffering from segmental, multifocal CD or from the Meige syndrome - Patients who developed anti-BTX (botulinumtoxin) antibodies - Other clinical conditions that might result in alteration of the outcomes of this clinical investigation (e.g. ageing voice) - Use of an active medical implant - Known allergies or intolerance to the material used for this clinical investigation - Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the clinical investigation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this clinical investigation is to determine whether electrical stimulation of the afferent fibers of the Ramus musculi trapezii could become an effective treatment for cervical dystonia according to the following outcome measures (immediately after the last stimulation session): - Bain rating - Clinical Global Impression – Severity scale (CGI-S) - Clinical Global Impression – Improvement scale (CGI-I) - CDQ-24 | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome The primary objective of this clinical investigation is to determine whether electrical stimulation of the afferent fibers of the Ramus musculi trapezii could become an effective treatment for cervical dystonia according to the following outcome measures (immediately after the last stimulation session): - Modified Tsui Scale for Cervical Dystonia - Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Visual analogue scale of pain | — |
Countries
Germany
Contacts
Public ContactGerd Fabian Volk
Klinik für Hals-, Nasen- und Ohrenheilkunde
Outcome results
None listed