Status:
UNKNOWN
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia
Lead Sponsor:
German Parkinson Study Group (GPS)
Collaborating Sponsors:
Medtronic
Competence Network on Parkinson's Disease
Conditions:
Dystonia
Eligibility:
All Genders
14-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.
Eligibility Criteria
Inclusion
- diagnosis of idiopathic multifocal, segmental or generalised dystonia
- duration of disease \> 5 years
- age between 14 and 75 years
- relevant disability in activities of daily living despite optimal drug treatment
- informed consent signed by the patient
- For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary
Exclusion
- Mattis-Score \< 120
- BDI \> 25
- previous stereotactic brain surgery
- severe brain atrophy
- increased bleeding risk
- immunosuppression and increased risk of infection
- relevant cerebrovascular disease
- psychiatric disorders, which might interfere with the cooperation in the study
- other contraindications for surgery
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00142259
Start Date
October 1 2002
End Date
August 1 2009
Last Update
December 6 2006
Active Locations (8)
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1
Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria, 6020
2
Klinikum der LMU, Neurologische Klinik
München, Bavaria, Germany, 81377
3
Neurologische Klinik am Klinikum der BJM-Universität
Würzburg, Bavaria, Germany, 97080
4
Department of Neurology, Charité, Humboldt-University Berlin
Berlin, State of Berlin, Germany, 13353