We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169403
First Posted: September 15, 2005
Last Update Posted: August 29, 2007
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.
Collaborator:
Délégation Régionale à la Recherche Clinique
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 12, 2005
First Posted: September 15, 2005
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:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases