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

Primary Purpose

Tourette Syndrome in Adolescence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral testing on cognitive computerized tasks
brain MRI
TMS
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tourette Syndrome in Adolescence

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Tourette syndrome

    Controls

    Arm Description

    Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures

    Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures

    Outcomes

    Primary Outcome Measures

    Behavioral test main outcome measures [1]
    reaction times
    Behavioral test main outcome measures [2]
    discounting factor
    Behavioral test main outcome measures [3]
    number of premature responses
    Behavioral test main outcome measures [4]
    agency composite scores
    Brain MRI scan measures
    whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology
    Transcranial magnetic stimulation
    intracortical inhibition (SICI) scores

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2019
    Last Updated
    November 25, 2019
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04179435
    Brief Title
    Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome
    Acronym
    CADETS
    Official Title
    Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tourette Syndrome in Adolescence

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Between group comparison
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tourette syndrome
    Arm Type
    Other
    Arm Description
    Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures
    Arm Title
    Controls
    Arm Type
    Other
    Arm Description
    Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral testing on cognitive computerized tasks
    Intervention Description
    Testing on cognitive computerized tasks
    Intervention Type
    Other
    Intervention Name(s)
    brain MRI
    Intervention Description
    Brain MRI scans
    Intervention Type
    Other
    Intervention Name(s)
    TMS
    Intervention Description
    Measure of the cortical inhibitory capacity using TMS measures
    Primary Outcome Measure Information:
    Title
    Behavioral test main outcome measures [1]
    Description
    reaction times
    Time Frame
    from 16 to 20 months
    Title
    Behavioral test main outcome measures [2]
    Description
    discounting factor
    Time Frame
    from 16 to 20 months
    Title
    Behavioral test main outcome measures [3]
    Description
    number of premature responses
    Time Frame
    from 16 to 20 months
    Title
    Behavioral test main outcome measures [4]
    Description
    agency composite scores
    Time Frame
    from 16 to 20 months
    Title
    Brain MRI scan measures
    Description
    whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology
    Time Frame
    from 16 to 20 months
    Title
    Transcranial magnetic stimulation
    Description
    intracortical inhibition (SICI) scores
    Time Frame
    from 16 to 20 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Worbe Yulia, MD, PhD
    Phone
    + 33 1 57 43 55
    Email
    Yulia.worbe@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Worbe Yulia, MD, PhD
    Organizational Affiliation
    Institut National de la Santé Et de la Recherche Médicale, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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