Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome

Tourette Syndrome in Adolescence Clinical Trial

— CADETS  

Official title:

Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04179435
• Other study ID #: C19-11
• Secondary ID: 2019-A00992-55
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: December 2023

Study information

• Verified date: November 2019
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Worbe Yulia, MD, PhD
• Phone: + 33 1 57 43 55
• Email: Yulia.worbe[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette Syndrome in Adolescence

Intervention

Behavioral:
• Behavioral testing on cognitive computerized tasks
Testing on cognitive computerized tasks

Other:
• brain MRI
Brain MRI scans
• TMS
Measure of the cortical inhibitory capacity using TMS measures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral test main outcome measures [1]	reaction times	from 16 to 20 months
Primary	Behavioral test main outcome measures [2]	discounting factor	from 16 to 20 months
Primary	Behavioral test main outcome measures [3]	number of premature responses	from 16 to 20 months
Primary	Behavioral test main outcome measures [4]	agency composite scores	from 16 to 20 months
Primary	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
Primary	Transcranial magnetic stimulation	intracortical inhibition (SICI) scores	from 16 to 20 months