Efficacy and Safety of Deep Brain Stimulation (DBS) of the Pallidal (GPi) in Patients With Tardive Dystonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Humboldt-Universität zu Berlin
Ruhr University of Bochum
Medical University of Cologne
Heinrich-Heine University, Duesseldorf
University Hospital Freiburg
Medical University of Hannover
Medical University Innsbruck
University of Kiel
Philipps University Marburg Medical Center
Ludwig-Maximilians - University of Munich
University of Rostock
University of Regensburg
University Hospital Tuebingen
Medical University of Vienna
Medtronic
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00331669
First received: May 26, 2006
Last updated: March 3, 2009
Last verified: February 2009
  Purpose

The purpose of this randomized, double blind, multi-center study is to assess the efficacy and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia.


Condition Intervention Phase
Dystonia
Movement Disorder
Procedure: deep brain stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Trial on the Effects of Pallidal Deep Brain Stimulation for Tardive Dystonia

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Improvement of the motor scale of Burke-Fahn-Marsden-Dystonia Rating Scale via blinded video assessment 3 months after starting DBS in comparison to sham-stimulated patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AIMS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Non-motor subscores of BMFDRS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Visual analogue scales for both patients and treating physicians [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Psychiatric assessment (HADS-D and PANSS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2006
Estimated Study Completion Date: December 2010
Arms Assigned Interventions
Placebo Comparator: 1
device
Procedure: deep brain stimulation
high frequency stimulation

Detailed Description:

Deep brain stimulation (DBS) has been established as a new reversible, neurosurgical therapeutic option for patients suffering from disabling neurological movement disorders such as essential tremor and Parkinson´s disease. Recently, deep brain stimulation has been successfully applied in patients with primary generalized and segmental dystonia. Additionally, a number of case reports suggest that pallidal deep brain stimulation may also improve tardive dystonia, which may for instance result from the intake of neuroleptics and which is notoriously difficult to treat medically. The present study will investigate the effects of pallidal DBS using a double blind, randomized design (sham- versus verum-stimulation within a 3-months interval post implantation of the electrodes).

Initially 60 patients had been calculated in a power analysis to assess significant results based on an average improvement of dystonic symptoms of 30%. However, in a recent study (Damier et al., Archives of General Psychiatry, 2007), 10 out of 10 showed a successful outcome of approximately 50% decrease on the extrapyramidal symptoms rating scale score. The exact one- sided lower 95% confidence limit would be 0.794 for this result. If such an approach is chosen for sample size estimation with 18 verum and 18 placebo patients one would obtain a power of 82% against a placebo effect of 30% success rate. For a placebo effect of 25% one needs 16+16 patients and for the placebo effect of 20% one needs 12+12 patients. We thus decided to reduce the sample size to 36- 32- 24 patients. It is expected that the continuous primary outcome measure will preserve even higher power than the binary one used in the study mentioned above. The local ethical committee has approved this.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Operational criteria for tardive dystonia for > 18 months after cessation of neuroleptic exposure
  • 18-75 years
  • Relevant functional impairment in daily living activities
  • BFMDRS > 8 or AIMS > 16
  • Informed written consent

Exclusion Criteria:

  • PANNS >60 (Schizophrenia)
  • Hamilton-Score > 18 (Depression)
  • MATTIS-Score <120 (Dementia)
  • Preceding stereotactic neurosurgery
  • Pronounced brain atrophy
  • Increased bleeding risk
  • Decreased immune status
  • Botulinum Toxin treatment within the last 3 months
  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: NCT00331669

Contacts
Contact: Andreas R Kupsch, MD, PhD xx49-30-450-50 ext 660103 andreas.kupsch@charite.de
Contact: Andrea Kuehn, MD xx49-30-450-50 ext 660203 andrea.kuehn@charite.de

Locations
Germany
Andreas Kupsch Recruiting
Berlin, Germany, 13353
Contact: Andreas R Kupsch, MD, PhD    xx49-30-450-50 ext 660103    andreas.kupsch@charite.de   
Contact: Andrea Kuehn, MD    xx49-30-450-50 ext 660203    andrea.kuehn@charite.de   
Principal Investigator: Andreas R Kupsch, MD, PhD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Humboldt-Universität zu Berlin
Ruhr University of Bochum
Medical University of Cologne
Heinrich-Heine University, Duesseldorf
University Hospital Freiburg
Medical University of Hannover
Medical University Innsbruck
University of Kiel
Philipps University Marburg Medical Center
Ludwig-Maximilians - University of Munich
University of Rostock
University of Regensburg
University Hospital Tuebingen
Medical University of Vienna
Medtronic
Investigators
Principal Investigator: Andreas R Kupsch, MD Dpt. of Neurology, Augustenburger Platz 1, 13353 Berlin, Charite, Campus Virchow, Germany
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00331669     History of Changes
Other Study ID Numbers: DBS and tardive dystonia
Study First Received: May 26, 2006
Last Updated: March 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
deep brain stimulation
pallidum
tardive dystonia
randomized
double blind
multicenter

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

ClinicalTrials.gov processed this record on July 28, 2014