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
  Purpose

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
Gilles de la Tourette Syndrome
Device: Deep brain stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 28
Study Start Date: November 2007
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Deep brain stimulation
Device: Deep brain stimulation
Deep brain stimulation
Other Name: Deep brain stimulation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478842

Contacts
Contact: Marie-Laure WELTER, MD,PhD +33(0)1 42 16 19 50 marie-laure.welter@psl.aphp.fr

Locations
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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie-Laure WELTER, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00478842     History of Changes
Other Study ID Numbers: P051050
Study First Received: May 24, 2007
Last Updated: July 27, 2012
Health Authority: France: Ministry of Health

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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014