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

Dystonia Clinical Trial

Official title:

Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00142259
• Other study ID #: 15
• Secondary ID: Grant: 01 GI 020
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: December 5, 2006
• Start date: October 2002
• Est. completion date: August 2009

Study information

• Verified date: September 2005
• Source: German Parkinson Study Group (GPS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

Device:
• Deep brain stimulation of the internal globus pallidus

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department of Neurology	Innsbruck	Tyrol
Germany	Department of Neurology, Charité, Humboldt-University Berlin	Berlin
Germany	Department of Neurology, University Heidelberg	Heidelberg
Germany	Dept. Neurology, UKSH Campus Kiel	Kiel
Germany	Klinikum der LMU, Neurologische Klinik	München	Bayern
Germany	Department of Neurology, University Rostock	Rostock
Germany	Neurologische Klinik am Klinikum der BJM-Universität	Würzburg	Bayern

Sponsors (3)

Lead Sponsor	Collaborator
German Parkinson Study Group (GPS)	Competence Network on Parkinson's Disease, Medtronic

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

Kupsch A, Benecke R, Müller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Müller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, V — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
Secondary	relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline

External Links

•   Homepage Competence Network on Parkinson`s disease sponsored by the German government