G24.3
Conditions
Interventions
Group 1: The approach assessed in this clinical investigation consists of bilateral surface electrostimulation delivered on the neck portion corresponding to the position of the relevant agonist and a
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 CD, independently whether their symptoms improve upon previous Botulin toxin injections, including patients suffering from Torticollis, Laterocollis, Anterocollis, Retrocollis of idiopathic or genetic origin • The effects of any previous treatments, including but not limited to Botulin toxin injection shall be completely faded at the time of enrolment • The concomitant presence of neck rotation (rotatory torticollis or rotatocollis), lateral shift, or sagittal shift do not constitute an exclusion criterion • Patients who developed anti-BTX antibodies are not excluded • Signed and dated informed consent before the start of any clinical investigation-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 • DBS users • Patients who underwent a previous CD surgery • Patients suffering from segmental, multifocal CD or from the Meige syndrome • Other clinical conditions that might result in alteration of the outcomes of this clinical investigation • 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 • Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical investigation is to determine whether the simultaneous application of electrostimulation to activate the hypofunctional agonistic activity (biphasic stimulation) and to reduce the activity of the hyperfunctional antagonistic activity (triphasic stimulation) will at least partially restore the correct posture of the head, neck, and upper chest in patients suffering from cervical dystonia according to the following outcome measures: • Modified Tsui Scale for Cervical Dystonia • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) • Visual analogue scale of pain | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this clinical investigation is to determine whether the simultaneous application of electrostimulation to activate the hypofunctional agonistic activity (biphasic stimulation) and to reduce the activity of the hyperfunctional antagonistic activity (triphasic stimulation) will at least partially restore the correct posture of the head, neck, and upper chest in patients suffering from cervical dystonia, according to the following outcome measures: • Bain rating • Clinical Global Impression rating scales for severity (CGI-S) completed at baseline visit and improvement (CGI-I) completed at the follow-up visits • CDQ-24 • 3D-Videos of cervical and head movements | — |
Countries
Austria, Germany
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed