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Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
This study is currently recruiting participants.
Study NCT00169403   Information provided by Groupe Hospitalier Pitie-Salpetriere
First Received: September 12, 2005   Last Updated: August 28, 2007   History of Changes

September 12, 2005
August 28, 2007
 
 
 
 
Complete list of historical versions of study NCT00169403 on ClinicalTrials.gov Archive Site
 
 
 
Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
 

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.
 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Dystonia
Procedure: Deep brain stimulation
 
Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
 

Inclusion Criteria:

  • Idiopathic generalised dystonia
  • Pallidal stimulation

Exclusion Criteria:

  • 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
 
NCT00169403
 
P000201
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