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

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

August 30, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Severity of tics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Tourette's Syndrome

Intervention ^ICMJE

Device: high frequency stimulation

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00139308

Responsible Party

Study ID Numbers ^ICMJE

RBM0008

Study Sponsor ^ICMJE

Groupe Hospitalier Pitie-Salpetriere

Collaborators ^ICMJE

Institut National de la Santé Et de la Recherche Médicale, France

Investigators ^ICMJE

Study Director:

Yves Agid, MD, PhD

CIC-Pitié-Salpêtrière

Information Provided By

Groupe Hospitalier Pitie-Salpetriere

Verification Date

August 2005

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