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

This study has been completed.
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
First received: August 30, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
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 Intervention Phase
Tourette's Syndrome
Device: high frequency stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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 NLM:

Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • Severity of tics


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00139308     History of Changes
Other Study ID Numbers: RBM0008 
Study First Received: August 30, 2005
Last Updated: August 30, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 24, 2016