Pallidal Stimulation in Patients With Post-Anoxic and Idiopathic Dystonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Délégation Régionale à la Recherche Clinique
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00169338
First received: September 12, 2005
Last updated: August 27, 2007
Last verified: September 2005

September 12, 2005
August 27, 2007
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Complete list of historical versions of study NCT00169338 on ClinicalTrials.gov Archive Site
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Pallidal Stimulation in Patients With Post-Anoxic and Idiopathic Dystonia
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Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.

Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dystonia
Procedure: Deep brain stimulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • Post-anoxic generalised dystonia
  • Idiopathic non-generalised dystonia
  • Disease duration > 1 year

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Mini-mental status (MMS) < 24
  • Severe psychiatric disorder
Both
15 Years to 65 Years
No
Contact: Marie Vidailhet, MD, PhD 33-142161950 marie.vidailhet@sat.ap-hop-paris.fr
Contact: Marie-Laure Welter, MD 33-142161950 marie-laure.welter@psl.aphp.fr
France
 
NCT00169338
P020918
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Groupe Hospitalier Pitie-Salpetriere
Délégation Régionale à la Recherche Clinique
Study Director: Marie Vidailhet, MD, PhD Hôpital Saint-Antoine
Groupe Hospitalier Pitie-Salpetriere
September 2005

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