Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

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. Identifier: NCT00169338
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2015
Information provided by (Responsible Party):
Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
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 or disease Intervention/treatment Phase
Dystonia Procedure: Deep brain stimulation Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2005
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Arm Intervention/treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00169338

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

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

Keywords provided by Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere:
deep brain stimulation
globus pallidus
Post-anoxic dystonia

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases