G24.3
Conditions
Interventions
Group 1: effective neurostimulation via implanted bilateral pallidal electrodes according to international clinical standards (90 µs pulse width, 130 Hz frequency, amplitude and choice of electrode co
Sponsors
Universitätsklinikum Würzburg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: * Diagnosis of primary cervical dystonia >= 2 years * Severity of dystonia >= 20 points on the TWSTRS total and >= 15 points on the TWSTRS motor scale * Age >= 18 years and = 25% score reduction on the TWSTRS motor scale at 4 weeks after a test injection. * Last injection of BoNT A >= 12 weeks before screening * Willingness to undergo pallidal deep brain stimulation surgery * Written informed consent for the participation after written and verbal information by trail physician
Exclusion criteria
Exclusion criteria: * Severity of dystonia 25 ) (earlier episodes of major depression in remission are not excluded) * Dementia or minimal cognitive impairment (Mattis Score = 125) * Acute psychosis (benign hallucinations or earlier psychotic episodes are not excluded) * Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy) * Analphabetism * Drug or alcohol addiction * Surgical contraindications against pallidal neurostimulation * Fertile women not using adequate contraceptive methods (hormonal contraception, spiral, surgical sterilisation) * Pregnancy or breast feeding * Simultaneous participation in another clinical treatment trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in TWSTRS total score between baseline and 6 months after stereotactic surgery with bilateral implantation of pallidal stimulation electrodes and generator under optimal therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| * Difference in Craniocervical Dystonia Questionnaire (CDQ-24) between baseline and 6 months after surgery under optimal therapy * Changes in TWSTRS motor score * Changes in TSUI score * Changes in SF-36 * Frequency and severity spontaneously reported adverse events/reactions under BoNT A injections and sham stimulation or neurostimulation and sham injections | — |
Countries
Germany
Contacts
Public ContactLeypold Christine
Universitätsklinikum Würzburg Neurologische Klinik und Poliklinik
Outcome results
None listed