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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00478842 |
The aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.
Condition | Intervention | Phase |
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Gilles de la Tourette Syndrome |
Device: Deep brain stimulation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS |
Estimated Enrollment: | 14 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Deep brain stimulation
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Device: Deep brain stimulation
Deep brain stimulation
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It acts of a randomized study, in parallel, double group blind, multi-centric relating to 14 patients.
The interest of this multicentric study, which will be carried out in centers specialized in the field of major cerebral stimulation with for each one a multidisciplinary team, is to carry out a homogeneous protocol which should make it possible to give a clear response in term of effectiveness for this treatment in this pathology.
The evaluation will be:
Calculations of the number of subjects necessary showed, by laying down the principal objective at an improvement of at least 60 % of the score of the YGTSS under treatment, which 14 subjects will make it possible to show a significant difference with the procedure placebo.
Study in Tomography by Emission of Positrons (Mtoe) carried out on 8 of the 14 operated patients having had at least 3 months of stimulation, in comparison on 8 pilot subjects (paired for the sex and the age), should make it possible to determine, at the time of the improvement of the driving symptoms, modifications of cerebral activation induced by the high frequency stimulation of GPI among patients.
The association of this study to the comparison of the improvement of the neurological symptoms with the precise localization of the therapeutic stud of the electrode reformatted on the post-operative TDM (8), carried out for all the patients, should make it possible to specify the anatomy-physiological bases to specify the anatomy-physiological bases of the MGT The duration of the study will be 14 month for each patient, that is to say one 2 months preoperative period intended for inclusion; one 3 months post-operative period without stimulation; one period randomized with stimulation either "one" (3 months), or "off" (3 months), then an open study for all the patients with stimulation "one" for one 6 months duration.
It is envisaged to include 14 patients reached of the MGT (of which 8 will take part in study Mtoe) and 8 subjects controls for study Mtoe is 22 subjects.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marie-Laure WELTER, MD,PhD | +33(0)1 42 16 19 50 | marie-laure.welter@psl.aphp.fr |
France | |
Groupe hospitalier la Pitié Salpétrière | Recruiting |
PARIS, France, 75013 | |
Contact: Marie-Laure WELTER, MD,PhD +33(0)1 42 16 19 50 marie-laure.welter@psl.aphp.fr |
Principal Investigator: | Marie-Laure WELTER, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Mathieu QUINTIN ) |
Study ID Numbers: | P051050 |
Study First Received: | May 24, 2007 |
Last Updated: | November 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00478842 |
Health Authority: | France: Ministry of Health |
Gilles de la Tourette syndrome Deep brain stimulation Globus PALLIDUS |
Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Brain Diseases Neurodegenerative Diseases |
Tics Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Movement Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Gilles de la Tourette's syndrome |
Pathologic Processes Disease Syndrome Nervous System Diseases |