Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia
NCT ID: NCT00142259
Last Updated: 2006-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2002-10-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Deep brain stimulation of the internal globus pallidus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
75 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Competence Network on Parkinson's Disease
OTHER
German Parkinson Study Group (GPS)
OTHER
Principal Investigators
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Jens Volkmann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. Neurology, UKSH Campus Kiel, Germany
Locations
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Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria
Klinikum der LMU, Neurologische Klinik
München, Bavaria, Germany
Neurologische Klinik am Klinikum der BJM-Universität
Würzburg, Bavaria, Germany
Department of Neurology, Charité, Humboldt-University Berlin
Berlin, State of Berlin, Germany
Düsseldorf, , Germany
Department of Neurology, University Heidelberg
Heidelberg, , Germany
Dept. Neurology, UKSH Campus Kiel
Kiel, , Germany
Department of Neurology, University Rostock
Rostock, , Germany
Countries
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References
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Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller 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, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.
Steigerwald F, Kirsch AD, Kuhn AA, Kupsch A, Mueller J, Eisner W, Deuschl G, Falk D, Schnitzler A, Skogseid IM, Vollmer-Haase J, Ip CW, Tronnier V, Vesper J, Naumann M, Volkmann J; DBS study group for dystonia. Evaluation of a programming algorithm for deep brain stimulation in dystonia used in a double-blind, sham-controlled multicenter study. Neurol Res Pract. 2019 Sep 24;1:25. doi: 10.1186/s42466-019-0032-2. eCollection 2019.
Volkmann J, Wolters A, Kupsch A, Muller J, Kuhn AA, Schneider GH, Poewe W, Hering S, Eisner W, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R; DBS study group for dystonia. Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol. 2012 Dec;11(12):1029-38. doi: 10.1016/S1474-4422(12)70257-0. Epub 2012 Nov 1.
Related Links
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Homepage Competence Network on Parkinson's disease sponsored by the German government
Other Identifiers
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Grant: 01 GI 0201 / 01 GI 0401
Identifier Type: -
Identifier Source: secondary_id
15
Identifier Type: -
Identifier Source: org_study_id