Pallidal Stimulation and Gilles de la Tourette Syndrome

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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