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Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169338
First Posted: September 15, 2005
Last Update Posted: September 15, 2015
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.
Information provided by (Responsible Party):
Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere:

Enrollment: 13
Study Start Date: September 2005
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deep brain stimulation
Paladin deep brain stimulation
Procedure: Deep brain stimulation
internal pallidal deep brain stimulation
Placebo Comparator: sham deep brain stimulation
no stimulation

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

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): NCT00169338


Locations
France
Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Paris, France
Sponsors and Collaborators
Marie-laure Welter
Investigators
Study Director: Marie Vidailhet, MD, PhD Hôpital Saint-Antoine
  More Information

Responsible Party: Marie-laure Welter, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT00169338     History of Changes
Other Study ID Numbers: P020918
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Marie-laure Welter, 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