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Pallidal Stimulation and Gilles de la Tourette Syndrome (STIC)

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ClinicalTrials.gov Identifier: NCT00478842
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Gilles de la Tourette Syndrome Device: Deep brain stimulation Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS
Study Start Date : November 2007
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Deep brain stimulation
Device: Deep brain stimulation
Deep brain stimulation



Primary Outcome Measures :
  1. 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. [ Time Frame: during the 44 months ]
  2. The assumption tested is that of the frank improvement (> 60% on scale YGTSS) of the symptoms of the MGT by the bilateral stimulation of GPI in its former part. [ Time Frame: at the end of 44 months ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: during the study ]
  2. To study the effects of the stimulation of GPI in its former part, on the driving tics simple and complex, vocal, the self-mutilations, and the psychopathology of which time, emotions and impulsiveness [ Time Frame: during the 44 months ]
  3. To evaluate the repercussion of this technique on the sociological-professional handicap, operation and the adaptation [ Time Frame: during the 44 months ]
  4. To seek determinants before intervention of the effectiveness of stimulation (determining neurological, psychiatric, neuropsychological, functional) [ Time Frame: during the 44 months ]
  5. To establish correlations between the localization of the studs of stimulation (retiming atlas/IRM) and the symptoms [ Time Frame: during the 44 months ]
  6. To determine the modifications of cerebral activation induced by the bilateral stimulation of GPI at the time of the improvement of the neurological symptoms (study in Mtoe). [ Time Frame: during the 44 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478842


Locations
France
Groupe hospitalier la Pitié Salpétrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie-Laure WELTER, MD,PhD Assistance Publique - Hôpitaux de Paris

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00478842     History of Changes
Other Study ID Numbers: P051050
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Gilles de la Tourette syndrome
Deep brain stimulation
Globus PALLIDUS

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders