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

In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.

Study Overview

• Status: Not yet recruiting
• Conditions: Tourette Syndrome in Adolescence
• Intervention / Treatment: Behavioral: Behavioral testing on cognitive computerized tasks; Other: brain MRI; Other: TMS

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: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Worbe Yulia, MD, PhD; Phone Number: + 33 1 57 43 55; Email: Yulia.worbe@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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)

Number of Arms

2

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	Behavioral: Behavioral testing on cognitive computerized tasks; Testing on cognitive computerized tasks; Other: brain MRI; Brain MRI scans; Other: TMS; Measure of the cortical inhibitory capacity using TMS measures
Other: Controls; Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures	Behavioral: Behavioral testing on cognitive computerized tasks; Testing on cognitive computerized tasks; Other: brain MRI; Brain MRI scans; Other: TMS; 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]	reaction times	from 16 to 20 months
Behavioral test main outcome measures [2]	discounting factor	from 16 to 20 months
Behavioral test main outcome measures [3]	number of premature responses	from 16 to 20 months
Behavioral test main outcome measures [4]	agency composite scores	from 16 to 20 months
Brain MRI scan measures	whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology	from 16 to 20 months
Transcranial magnetic stimulation	intracortical inhibition (SICI) scores	from 16 to 20 months

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Worbe Yulia, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No