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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
First received
Last updated
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
Health authority
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)

Study Design


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
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