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

March 3, 2009 updated by: Charite University, Berlin, Germany

Multicenter, Randomized Trial on the Effects of Pallidal Deep Brain Stimulation for Tardive Dystonia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Andreas Kupsch
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas R Kupsch, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
device
Procedure: deep brain stimulation
high frequency stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (SF-36)
Time Frame: 3 months
3 months
AIMS
Time Frame: 3 months
3 months
Non-motor subscores of BMFDRS
Time Frame: 3 months
3 months
Visual analogue scales for both patients and treating physicians
Time Frame: 3 months
3 months
Psychiatric assessment (HADS-D and PANSS)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Medical University of Vienna
Heinrich-Heine University, Duesseldorf
University of Kiel
Ludwig-Maximilians - University of Munich
Medtronic
Ruhr University of Bochum
Medical University Innsbruck
University Hospital Tuebingen
University Hospital Freiburg
Philipps University Marburg Medical Center
University of Rostock
University of Regensburg
Humboldt-Universität zu Berlin
Medical University of Hannover
Medical University of Cologne

Investigators

  • Principal Investigator: Andreas R Kupsch, MD, Dpt. of Neurology, Augustenburger Platz 1, 13353 Berlin, Charite, Campus Virchow, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

March 4, 2009

Last Update Submitted That Met QC Criteria

March 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBS and tardive dystonia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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