Pallidal Stimulation in Patients With Idiopathic Generalised 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:
NCT00169403
First received: September 12, 2005
Last updated: August 28, 2007
Last verified: September 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00169403     History of Changes
Other Study ID Numbers: P000201
Study First Received: September 12, 2005
Last Updated: August 28, 2007
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:
Dystonia
Dystonic Disorders
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014