Clinical trial NCT00142259: Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia
Official title: Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dystonia
Keywords: deep brain stimulation
internal globus pallidus
dystonia
Lead sponsor: German Parkinson Study Group (GPS)
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Competence Network on Parkinson's Disease
First posted: 2005-09-02
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
Secondary outcomes:
measure: relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Department of Neurology
state: Tyrol
city: München
country: Germany
facility: Klinikum der LMU, Neurologische Klinik
state: Bayern
city: Würzburg
country: Germany
facility: Neurologische Klinik am Klinikum der BJM-Universität
state: Bayern
city: Berlin
country: Germany
facility: Department of Neurology, Charité, Humboldt-University Berlin
city: Düsseldorf
country: Germany
city: Heidelberg
country: Germany
facility: Department of Neurology, University Heidelberg
city: Kiel
country: Germany
facility: Dept. Neurology, UKSH Campus Kiel
city: Rostock
country: Germany
facility: Department of Neurology, University Rostock
Study officials:
affiliation: Dept. Neurology, UKSH Campus Kiel, Germany
name: Jens Volkmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.