Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014