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

September 1, 2005
December 5, 2006
October 2002
Not Provided
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
Same as current
Complete list of historical versions of study NCT00142259 on ClinicalTrials.gov Archive Site
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia
Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dystonia
Device: Deep brain stimulation of the internal globus pallidus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
August 2009
Not Provided

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
Both
14 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00142259
15, Grant: 01 GI 0201 / 01 GI 0401
Not Provided
Not Provided
German Parkinson Study Group (GPS)
  • Medtronic
  • Competence Network on Parkinson's Disease
Principal Investigator: Jens Volkmann, MD, PhD Dept. Neurology, UKSH Campus Kiel, Germany
German Parkinson Study Group (GPS)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP