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

Primary Purpose

Dystonia

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Deep brain stimulation of the internal globus pallidus
Sponsored by
German Parkinson Study Group (GPS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia focused on measuring deep brain stimulation, internal globus pallidus, dystonia

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Innsbruck, Department of Neurology
  • Klinikum der LMU, Neurologische Klinik
  • Neurologische Klinik am Klinikum der BJM-Universität
  • Department of Neurology, Charité, Humboldt-University Berlin
  • Department of Neurology, University Heidelberg
  • Dept. Neurology, UKSH Campus Kiel
  • Department of Neurology, University Rostock

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2005
Last Updated
December 5, 2006
Sponsor
German Parkinson Study Group (GPS)
Collaborators
Medtronic, Competence Network on Parkinson's Disease
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1. Study Identification

Unique Protocol Identification Number
NCT00142259
Brief Title
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

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
German Parkinson Study Group (GPS)
Collaborators
Medtronic, Competence Network on Parkinson's Disease

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia
Keywords
deep brain stimulation, internal globus pallidus, dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Deep brain stimulation of the internal globus pallidus
Primary Outcome Measure Information:
Title
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
Secondary Outcome Measure Information:
Title
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Volkmann, MD, PhD
Organizational Affiliation
Dept. Neurology, UKSH Campus Kiel, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck, Department of Neurology
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinikum der LMU, Neurologische Klinik
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Neurologische Klinik am Klinikum der BJM-Universität
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Department of Neurology, Charité, Humboldt-University Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Düsseldorf
Country
Germany
Facility Name
Department of Neurology, University Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Dept. Neurology, UKSH Campus Kiel
City
Kiel
ZIP/Postal Code
24103
Country
Germany
Facility Name
Department of Neurology, University Rostock
City
Rostock
ZIP/Postal Code
18147
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17093249
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.
Results Reference
result
PubMed Identifier
33324891
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.
Results Reference
derived
PubMed Identifier
23123071
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.
Results Reference
derived
Links:
URL
http://www.kompetenznetz-parkinson.de
Description
Homepage Competence Network on Parkinson's disease sponsored by the German government

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

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