NCT04179435

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 20, 2019

Last Update Submit

November 25, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Tourette syndrome

OTHER

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

Behavioral: Behavioral testing on cognitive computerized tasksOther: brain MRIOther: TMS

Controls

OTHER

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

Behavioral: Behavioral testing on cognitive computerized tasksOther: brain MRIOther: TMS

Interventions

Testing on cognitive computerized tasks

ControlsTourette syndrome

Brain MRI scans

ControlsTourette syndrome
TMSOTHER

Measure of the cortical inhibitory capacity using TMS measures

ControlsTourette syndrome

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Worbe Yulia, MD, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Worbe Yulia, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Between group comparison
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 27, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share