Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

August 28, 2007 updated by: Groupe Hospitalier Pitie-Salpetriere

Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:

evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
assess the recurrence of the motor symptoms after the switch off.

Study Overview

Status

Unknown

Conditions

Dystonia

Intervention / Treatment

Procedure: Deep brain stimulation

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France
    - Recruiting
    - Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
    - Contact:
      
      Marie-Laure Welter, MD
      
      Phone Number: 33-142161950
      
      Email: marie-laure.welter@psl.aphp.fr
    - Principal Investigator:
      
      Marie Vidailhet, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Idiopathic generalised dystonia
Pallidal stimulation

Exclusion Criteria:

Mini-mental status (MMS) < 24
Severe psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

University Hospital, Tours

Investigators

Study Director: Marie Vidailhet, MD, PhD, Hôpital Saint-Antoine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1056/NEJMoa042187.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 29, 2007

Last Update Submitted That Met QC Criteria

August 28, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

P000201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.