Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia

Phase 4

• Conditions: Dystonia

• Registration Number: NCT00142259
• Lead Sponsor: German Parkinson Study Group (GPS)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Last Update Submitted: 2006-12-05
• Last Update Posted: 2006-12-06
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline

Secondary Outcome Measures

Name	Time	Method
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline

Trial Locations

Locations (7)

Klinikum der LMU, Neurologische Klinik; 🇩🇪 München, Bayern, Germany

Medical University Innsbruck, Department of Neurology; 🇦🇹 Innsbruck, Tyrol, Austria

Department of Neurology, University Rostock; 🇩🇪 Rostock, Germany

Department of Neurology, University Heidelberg; 🇩🇪 Heidelberg, Germany

Dept. Neurology, UKSH Campus Kiel; 🇩🇪 Kiel, Germany

Neurologische Klinik am Klinikum der BJM-Universität; 🇩🇪 Würzburg, Bayern, Germany

Department of Neurology, Charité, Humboldt-University Berlin; 🇩🇪 Berlin, Germany