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Tourette Syndrome in AdolescenceCADETSNCT04179435

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

A study testing Behavioral testing on cognitive computerized tasks, brain MRI and TMS in people with Tourette Syndrome in Adolescence, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Tourette Syndrome in Adolescence
What is being tested?
Behavioral testing on cognitive computerized tasks, brain MRI and TMS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteFrance
Study dates
11 Dec 2019to 18 Jun 2024
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Tourette syndrome
  • Ages 13 - 18
  • Acceptance to perform the Brain MRI
  • Acceptance to perform the cognitive testing
  • Acceptance to perform the TMS measures

Who cannot join

  • Learning disability
  • Incompatibility with MRI procedure (metal body implants, pregnancy)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Behavioral testing on cognitive computerized tasks, brain MRI, TMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral testing on cognitive computerized tasksBehavioural

    Testing on cognitive computerized tasks

  • brain MRIOther

    Brain MRI scans

  • TMSOther

    Measure of the cortical inhibitory capacity using TMS measures

Study groups in NCT04179435
Study groupRoleWhat they receive
Tourette syndromeOtherPatients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures
Receives: Behavioral: Behavioral testing on cognitive computerized tasks; Other: brain MRI; Other: TMS
ControlsOtherControls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures
Receives: Behavioral: Behavioral testing on cognitive computerized tasks; Other: brain MRI; Other: TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Behavioral test main outcome measures [1]

    reaction times

    Measured: from 16 to 20 months

  2. Behavioral test main outcome measures [2]

    discounting factor

    Measured: from 16 to 20 months

  3. Behavioral test main outcome measures [3]

    number of premature responses

    Measured: from 16 to 20 months

  4. Behavioral test main outcome measures [4]

    agency composite scores

    Measured: from 16 to 20 months

  5. Brain MRI scan measures

    whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology

    Measured: from 16 to 20 months

  6. Transcranial magnetic stimulation

    Short Intracortical Inhibition (SICI) scores

    Measured: from 16 to 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start11 Dec 2019
  3. Primary completion18 Jun 2024
  4. Study completion18 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Between group comparison
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179435
Sponsor's protocol ID
C19-11
Other IDs
2019-A00992-55
Acronym
CADETS
Status last verified
Jun 2026
First submitted
20 Nov 2019
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Atkinson-Clement C, Duflot M, Lastennet E, Patsalides L, Wasserman E, Sartoris TM, Tarrano C, Rosso C, Burbaud P, Deniau E, Czernecki V, Roze E, Hartmann A, Worbe Y. How does Tourette syndrome impact adolescents' daily living? A text mining study. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2623-2635. doi: 10.1007/s00787-022-02116-1. Epub 2022 Dec 2.

    PubMed 36460852

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