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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by German Parkinson Study Group (GPS).
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Medtronic

Competence Network on Parkinson's Disease

Information provided by:

German Parkinson Study Group (GPS)

ClinicalTrials.gov Identifier:

NCT00142259

First received: September 1, 2005

Last updated: December 5, 2006

Last verified: September 2005

History of Changes

Purpose

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.

Condition	Intervention	Phase
Dystonia	Device: Deep brain stimulation of the internal globus pallidus	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie

Resource links provided by NLM:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia

MedlinePlus related topics: Dystonia

U.S. FDA Resources

Further study details as provided by German Parkinson Study Group (GPS):

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

Estimated Enrollment:	40
Study Start Date:	October 2002
Estimated Study Completion Date:	August 2009

Eligibility

Ages Eligible for Study:	14 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142259

Locations

Austria
Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria, 6020
Germany
Klinikum der LMU, Neurologische Klinik
München, Bayern, Germany, 81377
Neurologische Klinik am Klinikum der BJM-Universität
Würzburg, Bayern, Germany, 97080
Department of Neurology, Charité, Humboldt-University Berlin
Berlin, Germany, 13353

Düsseldorf, Germany
Department of Neurology, University Heidelberg
Heidelberg, Germany, 69120
Dept. Neurology, UKSH Campus Kiel
Kiel, Germany, 24103
Department of Neurology, University Rostock
Rostock, Germany, 18147

Sponsors and Collaborators

German Parkinson Study Group (GPS)

Medtronic

Competence Network on Parkinson's Disease

Investigators

Principal Investigator:

Jens Volkmann, MD, PhD

Dept. Neurology, UKSH Campus Kiel, Germany

More Information

Additional Information:

Homepage Competence Network on Parkinson`s disease sponsored by the German government This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Volkmann J, Wolters A, Kupsch A, Müller J, Kühn AA, Schneider GH, Poewe W, Hering S, Eisner W, Müller 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.

ClinicalTrials.gov Identifier:	NCT00142259 History of Changes
Other Study ID Numbers:	15, Grant: 01 GI 0201 / 01 GI 0401
Study First Received:	September 1, 2005
Last Updated:	December 5, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Parkinson Study Group (GPS):

deep brain stimulation
internal globus pallidus
dystonia

Additional relevant MeSH terms:

Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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