Clinical Trial: Double-Blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients with Medically Refractory Primary Cervical Dystonia

This study is currently recruiting patients.
Verified by German Parkinson Study Group (GPS) September 2005

Sponsors and Collaborators: German Parkinson Study Group (GPS)
Medtronic Europe SA, Route du Molliau, CH-1131 Tolochenaz, Switzerland
Competence Network on Parkinson`s disease
Information provided by: German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier: NCT00148889

Purpose

The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.
Condition Intervention Phase
Cervical dystonia
 Device: Deep brain stimulation (DBS)
Phase III

MedlinePlus related topics:  Dystonia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Prospective,Randomised, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Bilateral Globus Pallidus Internus - in Patients with Medically Refractory Primary Cervical Dystonia

Further Study Details: 
Primary Outcomes: Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)
Secondary Outcomes: - side-effects; - quality of life; - depression; - pain
Expected Total Enrollment:  40

Study start: July 2005
Last follow-up: August 2005;  Data entry closure: August 2005

Primary cervical dystonia (CD) affects about 20-40/100.000 population. The disease is chronic and life-long. The therapy of choice are local intramuscular Botulinum Toxin injections given every three months. Oral medication such as anticholinergics or dopamine depleting drugs are usually of limited efficacy or their use is limited by intolerable side-effects. About 5-10% of CD patients develop neutralizing antibodies against Botulinum Toxin. Two previous controlled multicenter trials have shown the efficacy and safety of bilateral pallidal stimulation in patients with primary segmental and generalized dystonia (one study was performed by our group).

Following surgery, patients will be randomized 1:1 to verum or placebo stimulation for a period of three months. Primary outcome measure is the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) - a validated and widely accepted physician-based outcome measure for cervical dystonia. The independent TWSTRS raters are movement disorders specialists unaware of the stimulation status (verum/placebo) and they compare the TWSTRS-score at baseline and 3-months follow-up. Our hypothesis is that stimulated patients will have a significantly better improvement of dystonia as compared to those without stimulation (placebo group).

After the 3-months period, all patients are unblinded and receive continuous effective stimulation by the implanted system. Regular follow-up visits are scheduled every 12 months for 5 years postoperatively to assess the long-term efficacy of pallidal stimulation. Side-effects are assessed in a standardized way and include the assessment of surgery-induced as well as stimulation-induced side-effects.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Primary cervical dystonia
  • Disease duration 3 years or longer
  • Adult patient (18 years or older)
  • TWSTRS severity score 15 or more
  • Non-response to Botulinum Toxin
  • Non-response to oral antidystonic medication
  • Informed consent

Exclusion Criteria:

  • Dementia (Mattis Dementia Rating Scale below 120)
  • Severe depression (Beck Depression Inventory >25)
  • Previous functional stereotactic surgery
  • Hemidystonia or generalized dystonia
  • Severe brain atrophy
  • Contraindication against surgery

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148889

Joerg Mueller, MD      0043-512-504  Ext. 23850    joerg.mueller@uibk.ac.at

Austria
      Department of Neurosurgery, Medical University Vienna, Vienna,  1090,  Austria; Not yet recruiting
Francois Alesch, MD  0043-1-40400  Ext. 2570    francois.alesch@meduniwien.ac.at 
Francois Alesch, MD,  Principal Investigator

Austria, Tyrol
      Medical University Innsbruck, Department of Neurology, Innsbruck,  Tyrol,  6020,  Austria; Recruiting
Joerg Mueller, MD  0043-512-504  Ext. 23850    joerg.mueller@uibk.ac.at 
Joerg Mueller, MD,  Principal Investigator

Germany
      Department of Neurology, University Rostock, Rostock,  18147,  Germany; Not yet recruiting
Reiner Benecke, MD  0049-3814940    reiner.benecke@med.uni-rostock.de 
Reiner Benecke, MD,  Principal Investigator

      Department of Neurology, University Kiel, Kiel,  24105,  Germany; Not yet recruiting
Jens Volkmann, MD  0049-431-597  Ext. 8509    j.volkmann@neurologie.uni-kiel.de 
Jens Volkmann, MD,  Principal Investigator

      Department for Stereotaxy and Functional Neurosurgery, University Cologne, Köln,  50937,  Germany; Not yet recruiting
Juergen Voges, MD  0049-221-478  Ext. 4580    j.voges@uni-koeln.de 
Juergen Voges, MD,  Principal Investigator

      Clinic of Neurosurgery, Medical University Hannover, Hannover,  30625,  Germany; Not yet recruiting
Joachim Krauss, MD  0049-511-532  Ext. 3102 
Joachim Krauss, MD,  Principal Investigator

      Hertie-Institute for Clinical Brain Research, Tübingen,  72076,  Germany; Not yet recruiting
Friedrich Asmus, MD  0049-7071-29  Ext. 87640    friedrich.asmus@med.uni-tuebingen.de 
Friedrich Asmus, MD,  Principal Investigator

      Department of Neurology, University Regensburg, Regensburg,  93053,  Germany; Not yet recruiting
Max Lange, MD  0049-941  Ext. 9410    max.lange@medbo.de 
Max Lange, MD,  Principal Investigator

      Department of Neurology, University Heidelberg, Heidelberg,  69120,  Germany; Not yet recruiting
Martin Krause, MD  0049-6221  Ext. 567504    martin.krause@med.uni-heidelberg.de 
Martin Krause, MD,  Principal Investigator

      Department of Neurology, Charité, Humboldt-University Berlin, Berlin,  13353,  Germany; Not yet recruiting
Andreas Kupsch, Dr.  +49 030-450 660 103    andreas.kupsch@charite.de 
Klaus Maier-Hauff, Prof. Dr.   klausmaierhauff@bundeswehr.org 
Andreas Kupsch, MD,  Principal Investigator

Study chairs or principal investigators

Joerg Mueller, MD,  Principal Investigator,  Department of Neurology, Medical University Innsbruck, Anichstr. 35, A-6020 Innsbruck, Austria   

More Information

Study ID Numbers:  CD-DBS-2005-JM
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00148889
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13

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