- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139308
High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
August 30, 2005 updated by: Groupe Hospitalier Pitie-Salpetriere
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75013
- Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Severity of tics
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yves Agid, MD, PhD, CIC-Pitié-Salpêtrière
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
August 31, 2005
Study Record Updates
Last Update Posted (Estimate)
August 31, 2005
Last Update Submitted That Met QC Criteria
August 30, 2005
Last Verified
August 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
Other Study ID Numbers
- RBM0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tourette's Syndrome
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Otsuka Pharmaceutical Development & Commercialization...TerminatedTourette's Disorder (TD)United States, Canada, Hungary
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Emalex Biosciences Inc.Psyadon PharmaCompleted
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