Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478842
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2007-05-24
Brief Title:
Pallidal Stimulation and Gilles de la Tourette Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STIC
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None