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High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome

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ClinicalTrials.gov Identifier: NCT00139308
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 31, 2005
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.

Condition or disease Intervention/treatment Phase
Tourette's Syndrome Device: high frequency stimulation Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Severity of tics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Tourette's syndrome (DSM IV)
  • inducing a disability in the social and personal life
  • No improvement with medical treatment
  • Severe self suffering

Exclusion Criteria:

  • Cognitive impairment (MMS < 24)
  • Depression

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): NCT00139308

Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Institut National de la Santé Et de la Recherche Médicale, France
Study Director: Yves Agid, MD, PhD CIC-Pitié-Salpêtrière

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00139308     History of Changes
Other Study ID Numbers: RBM0008
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 31, 2005
Last Verified: August 2005

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Tourette's syndrome
High frequency stimulation
Globus pallidus

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders