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Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
This study is currently recruiting participants.
Verified by Groupe Hospitalier Pitie-Salpetriere, September 2005
First Received: September 12, 2005   Last Updated: August 28, 2007   History of Changes
Sponsor: Groupe Hospitalier Pitie-Salpetriere
Collaborator: Délégation Régionale à la Recherche Clinique
Information provided by: Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT00169403
  Purpose

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 Intervention Phase
Dystonia
 Procedure: Deep brain stimulation
 Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia
MedlinePlus related topics: Dystonia
U.S. FDA Resources
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic generalised dystonia
  • Pallidal stimulation

Exclusion Criteria:

  • Mini-mental status (MMS) < 24
  • Severe psychiatric disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169403

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

Locations
France
Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere Recruiting
Paris, France
Contact: Marie-Laure Welter, MD     33-142161950     marie-laure.welter@psl.aphp.fr    
Principal Investigator: Marie Vidailhet, MD, PhD            
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Délégation Régionale à la Recherche Clinique
Investigators
Study Director: Marie Vidailhet, MD, PhD Hôpital Saint-Antoine
  More Information

Publications:
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.

Study ID Numbers: P000201
Study First Received: September 12, 2005
Last Updated: August 28, 2007
ClinicalTrials.gov Identifier: NCT00169403     History of Changes
Health Authority: France: Ministry of Health

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Idiopathic dystonia
deep brain stimulation
globus pallidus
generalised Idiopathic dystonia

Additional relevant MeSH terms:
Dystonic Disorders
Signs and Symptoms
Movement Disorders
Nervous System Diseases
 Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Dyskinesias

ClinicalTrials.gov processed this record on November 27, 2009



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