- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179435
Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome (CADETS)
Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thus, the aims of the present project is threefold:
Aim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.
To achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.
Aim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.
Aim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Paris, France, 75013
- Hôpital de la Pitié-Salpêtrière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Tourette syndrome
- Ages 13 - 18
- Acceptance to perform the Brain MRI
- Acceptance to perform the cognitive testing
- Acceptance to perform the TMS measures
Exclusion Criteria:
- Learning disability
- Incompatibility with MRI procedure (metal body implants, pregnancy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Tourette syndrome
Patients with Tourette syndrome aged 13 - 18 y.o.
Interventions : Brain scans, cognitive testing, TMS measures
|
Testing on cognitive computerized tasks
Brain MRI scans
Measure of the cortical inhibitory capacity using TMS measures
|
|
Other: Controls
Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures
|
Testing on cognitive computerized tasks
Brain MRI scans
Measure of the cortical inhibitory capacity using TMS measures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral test main outcome measures [1]
Time Frame: from 16 to 20 months
|
reaction times
|
from 16 to 20 months
|
|
Behavioral test main outcome measures [2]
Time Frame: from 16 to 20 months
|
discounting factor
|
from 16 to 20 months
|
|
Behavioral test main outcome measures [3]
Time Frame: from 16 to 20 months
|
number of premature responses
|
from 16 to 20 months
|
|
Behavioral test main outcome measures [4]
Time Frame: from 16 to 20 months
|
agency composite scores
|
from 16 to 20 months
|
|
Brain MRI scan measures
Time Frame: from 16 to 20 months
|
whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology
|
from 16 to 20 months
|
|
Transcranial magnetic stimulation
Time Frame: from 16 to 20 months
|
Short Intracortical Inhibition (SICI) scores
|
from 16 to 20 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Worbe Yulia, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
Other Study ID Numbers
- C19-11
- 2019-A00992-55 (Registry Identifier: CADETS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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