Pallidal Stimulation and Gilles de la Tourette Syndrome (STIC)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00478842

First received: May 24, 2007

Last updated: July 27, 2012

Last verified: May 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2007

Last Updated Date

July 27, 2012

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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 ]
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 ]

Change History

Complete list of historical versions of study NCT00478842 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
To evaluate the repercussion of this technique on the sociological-professional handicap, operation and the adaptation [ Time Frame: during the 44 months ] [ Designated as safety issue: No ]
To seek determinants before intervention of the effectiveness of stimulation (determining neurological, psychiatric, neuropsychological, functional) [ Time Frame: during the 44 months ] [ Designated as safety issue: Yes ]
To establish correlations between the localization of the studs of stimulation (retiming atlas/IRM) and the symptoms [ Time Frame: during the 44 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 ]
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 ]
To evaluate the repercussion of this technique on the sociological-professional handicap, operation and the adaptation [ Time Frame: during the 44 months ]
To seek determinants before intervention of the effectiveness of stimulation (determining neurological, psychiatric, neuropsychological, functional) [ Time Frame: during the 44 months ]
To establish correlations between the localization of the studs of stimulation (retiming atlas/IRM) and the symptoms [ Time Frame: during the 44 months ]
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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pallidal Stimulation and Gilles de la Tourette Syndrome

Official Title ^ICMJE

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:

neurological (YGTSS, video scale of the tics);
psychiatric, with in particular of the specific psychopathological evaluations centered on mood;
neuropsychological, centered on impulsiveness;
functional calculus evaluating total operation and the social adaptation;
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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Gilles de la Tourette Syndrome

Intervention ^ICMJE

Device: Deep brain stimulation

Deep brain stimulation

Other Name: Deep brain stimulation

Study Arm (s)

Experimental: 1

Deep brain stimulation

Intervention: Device: Deep brain stimulation

Publications *

Houeto JL, Karachi C, Mallet L, Pillon B, Yelnik J, Mesnage V, Welter ML, Navarro S, Pelissolo A, Damier P, Pidoux B, Dormont D, Cornu P, Agid Y. Tourette's syndrome and deep brain stimulation. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):992-5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marie-Laure WELTER, MD,PhD

+33(0)1 42 16 19 50

marie-laure.welter@psl.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00478842

Other Study ID Numbers ^ICMJE

P051050

Has Data Monitoring Committee

Yes

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marie-Laure WELTER, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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