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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139308
First Posted: August 31, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
August 30, 2005
August 31, 2005
December 9, 2005
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Severity of tics
Same as current
No Changes Posted
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High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
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
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.
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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Tourette's Syndrome
Device: high frequency stimulation
Not Provided
Welter ML, Mallet L, Houeto JL, Karachi C, Czernecki V, Cornu P, Navarro S, Pidoux B, Dormont D, Bardinet E, Yelnik J, Damier P, Agid Y. Internal pallidal and thalamic stimulation in patients with Tourette syndrome. Arch Neurol. 2008 Jul;65(7):952-7. doi: 10.1001/archneur.65.7.952.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00139308
RBM0008
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Groupe Hospitalier Pitie-Salpetriere
Institut National de la Santé Et de la Recherche Médicale, France
Study Director: Yves Agid, MD, PhD CIC-Pitié-Salpêtrière
Groupe Hospitalier Pitie-Salpetriere
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP