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Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

This study is currently recruiting participants.
Study NCT00169403.   Last updated on August 28, 2007.   Information provided by Groupe Hospitalier Pitie-Salpetriere

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Descriptive Information Fields
Brief Title  Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
Official Title 
Brief Summary

Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:

  1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
  2. assess the recurrence of the motor symptoms after the switch off.
Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Dystonia
Intervention  Procedure: Deep brain stimulation
MEDLINE PMIDs 15689584
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Idiopathic generalised dystonia
  • Pallidal stimulation

Exclusion Criteria:

  • Mini-mental status (MMS) < 24
  • Severe psychiatric disorder
Gender Both
Ages 15 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
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    
Location Countries  France
Administrative Information Fields
NCT ID  NCT00169403
Organization ID P000201
Secondary IDs ††
Study Sponsor  Groupe Hospitalier Pitie-Salpetriere
Collaborators †† Délégation Régionale à la Recherche Clinique
Investigators 
Study Director:     Marie Vidailhet, MD, PhD     Hôpital Saint-Antoine    
Information Provided By Groupe Hospitalier Pitie-Salpetriere
Verification Date September 2005
First Received Date  September 12, 2005
Last Updated Date August 28, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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