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Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169403
Recruitment Status : Unknown
Verified September 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : August 29, 2007
University Hospital, Tours
Information provided by:
Groupe Hospitalier Pitie-Salpetriere

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.

Condition or disease Intervention/treatment Phase
Dystonia Procedure: Deep brain stimulation Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Idiopathic generalised dystonia
  • Pallidal stimulation

Exclusion Criteria:

  • Mini-mental status (MMS) < 24
  • Severe psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169403

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Contact: Marie Vidailhet, MD, PhD 33-142161950
Contact: Marie-Laure Welter, MD 33-142161950

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Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere Recruiting
Paris, France
Contact: Marie-Laure Welter, MD    33-142161950   
Principal Investigator: Marie Vidailhet, MD, PhD         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Tours
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Study Director: Marie Vidailhet, MD, PhD Hôpital Saint-Antoine
Publications of Results:
Layout table for additonal information Identifier: NCT00169403    
Other Study ID Numbers: P000201
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: September 2005
Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Idiopathic dystonia
deep brain stimulation
globus pallidus
generalised Idiopathic dystonia
Additional relevant MeSH terms:
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Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases