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

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Competence Network on Parkinson's Disease
Information provided by:
German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier:
NCT00148889
First received: September 7, 2005
Last updated: February 10, 2009
Last verified: February 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • side-effects, quality of life, depression, pain, long-term efficacy [ Time Frame: 5 years ]

Enrollment: 63
Study Start Date: July 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 2
Sham-stimulation
Device: Deep brain stimulation (DBS)
Bilateral pallidal stimulation with an implanted DBS device
Active Comparator: 1
Active GPI-DBS
Device: Deep brain stimulation (DBS)
Bilateral pallidal stimulation with an implanted DBS device

Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00148889

Locations
Austria
Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria, 6020
Department of Neurosurgery, Medical University Vienna
Vienna, Austria, 1090
Germany
Department of Neurology, Charité, Humboldt-University Berlin
Berlin, Germany, 13353
Clinic of Neurosurgery, Medical University Hannover
Hannover, Germany, 30625
Department of Neurology, University Heidelberg
Heidelberg, Germany, 69120
Department of Neurology, University Kiel
Kiel, Germany, 24105
Department for Stereotaxy and Functional Neurosurgery, University Cologne
Köln, Germany, 50937
Department of Neurology, University Regensburg
Regensburg, Germany, 93053
Department of Neurology, University Rostock
Rostock, Germany, 18147
Hertie-Institute for Clinical Brain Research
Tübingen, Germany, 72076
Sponsors and Collaborators
German Parkinson Study Group (GPS)
Medtronic
Competence Network on Parkinson's Disease
Investigators
Principal Investigator: Joerg Mueller, MD Department of Neurology, Medical University Innsbruck, Anichstr. 35, A-6020 Innsbruck, Austria
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. J. Mueller, Dep. of Neurology, Medical University Innsbruck, Austria
ClinicalTrials.gov Identifier: NCT00148889     History of Changes
Other Study ID Numbers: CD-DBS-2005-JM
Study First Received: September 7, 2005
Last Updated: February 10, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Parkinson Study Group (GPS):
cervical dystonia
torticollis
deep brain stimulation
pallidal stimulation
globus pallidus internus

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014