Evaluation of the therapeutic effects of surface electrostimulation on patients suffering from cervical dystonia

Phase 1

Conditions: G24.3
Spasmodic torticollis

Registration Number: DRKS00024595

Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 5

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

• 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