Brief Title
Pallidal Stimulation and Gilles de la Tourette Syndrome
Official Title
Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS
Brief Summary
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.
Detailed Description
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: 1. neurological (YGTSS, video scale of the tics); 2. psychiatric, with in particular of the specific psychopathological evaluations centered on mood; 3. neuropsychological, centered on impulsiveness; 4. functional calculus evaluating total operation and the social adaptation; 5. neurophysiological (recording of the neuronal activities). 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. An observational follow-up at 30 and 48 months is added.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
To evaluate the therapeutic effect of the high frequency bilateral stimulation of GPI in severe forms and invalidating MGT, in a protocol randomized as a double blind man in parallel groups.
Secondary Outcome
To evaluate time necessary to obtaining the maximum effect and its evolution after this one (maintenance or not of the effect in the course of time)
Condition
Gilles de la Tourette Syndrome
Intervention
Deep brain stimulation
Study Arms / Comparison Groups
1
Description: Deep brain stimulation
Publications
* 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
Device
Estimated Enrollment
20
Start Date
November 2007
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria: - Severe form of GTS - age 18 to 60 years - failure of medical treatment (including neuroleptics) Exclusion Criteria: - Major depression - Psychotic symptoms - Severe personality disorder
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Marie-Laure WELTER, MD,PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00478842
Organization ID
P051050
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Marie-Laure WELTER, MD,PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
February 2017