Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

This study has been completed.
Information provided by (Responsible Party):
Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere Identifier:
First received: September 12, 2005
Last updated: September 14, 2015
Last verified: September 2015
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
Procedure: Deep brain stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by 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.

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Marie-laure Welter, MD, PhD, Groupe Hospitalier Pitie-Salpetriere Identifier: NCT00169338     History of Changes
Other Study ID Numbers: P020918
Study First Received: September 12, 2005
Last Updated: September 14, 2015
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Dystonic Disorders
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on November 25, 2015