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

First Received on September 12, 2005. Last Updated on August 27, 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:	NCT00169338

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 II

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:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

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 February 12, 2012