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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Dystonia
 Procedure: Deep brain stimulation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Detailed Description:

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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169338

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

No publications provided

ClinicalTrials.gov Identifier: NCT00169338     History of Changes
Other Study ID Numbers: P020918
Study First Received: September 12, 2005
Last Updated: August 27, 2007
Health Authority: France: Ministry of Health

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Dystonia
deep brain stimulation
globus pallidus
Post-anoxic dystonia

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

ClinicalTrials.gov processed this record on May 23, 2013