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

This study has been completed.

First Received on August 30, 2005. No Changes Posted

Sponsor:	Groupe Hospitalier Pitie-Salpetriere
Collaborator:	Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:	NCT00139308

Purpose

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 I

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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome

MedlinePlus related topics: Tourette Syndrome

U.S. FDA Resources

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

Primary Outcome Measures:

Severity of tics

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139308

Locations

France
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

Investigators

Study Director:

Yves Agid, MD, PhD

CIC-Pitié-Salpêtrière

More Information

No publications provided by Groupe Hospitalier Pitie-Salpetriere

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 - French Health Products Safety Agency

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:

Tourette's syndrome
High frequency stimulation
Globus pallidus
Thalamus

Additional relevant MeSH terms:

Tourette Syndrome
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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012