NCT02960698

Brief Summary

Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Its anatomical substrates is based on connections between frontal and striatal areas. Initially, a battery of behavioral tests measuring different types of impulsivity (motor, cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40 patients treated and 40 untreated) and 40 healthy volunteers. Then, investigators will study the fronto-striatal connections in the TS group of 80 patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study of "resting state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging data to highlight the functional anatomical substrates of impulsivity in patients with TS. Finally, investigators will look specifically using functional MRI activation, the anatomical and functional substrates of the three types of impulsivity (motor, cognitive and decision-making). Through this study, investigators hope to elucidate the anatomical and functional bases of cognitive impulsivity in patients with TS and thus lay the basis for more targeted treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 14, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

October 27, 2016

Last Update Submit

August 28, 2025

Conditions

Keywords

cognitive impulsivityIRMTourette Syndrome

Outcome Measures

Primary Outcomes (2)

  • behavior performance (percentage of correct responses and reaction time)

    up to one month

  • BOLD signal of functional MRI scan

    up to one month

Study Arms (3)

TREATED PATIENT WITH TOURETTE SYNDROME

ACTIVE COMPARATOR

comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients

Other: IRM and comportemental tasks

UNTREATED PATIENT WITH TOURETTE SYNDROME

ACTIVE COMPARATOR

comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients

Other: IRM and comportemental tasks

Healthy volunteers

PLACEBO COMPARATOR

comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects

Other: IRM and comportemental tasks

Interventions

Healthy volunteersTREATED PATIENT WITH TOURETTE SYNDROMEUNTREATED PATIENT WITH TOURETTE SYNDROME

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all subjects:
  • ≥ about 18 and 65 years old
  • About receiving Social Security or universal health coverage or any equivalent plan
  • About who signed the informed consent
  • For TS patients treated :
  • TS principal diagnosis, based on the DSM-5 criteria
  • Stable pharmacological treatment at least 4 weeks prior to study entry;
  • Possibility of controlling the majority tics of the upper part of the body lying down for at least 10 minutes (frequency tics on YGTSS \<3).
  • For TS patients untreated:
  • TS principal diagnosis, based on the DSM-5 criteria
  • Possibility of controlling the majority tics of the upper part of the body lying down for at least 10 minutes (frequency tics on YGTSS \<3).
  • In healthy volunteers:
  • Normal neurological examination (evaluation MINI).
  • No regular pharmacological treatment with the exception of birth control pills for women

You may not qualify if:

  • For all patients TS:
  • Age \<18 years.
  • Presence One of the following diagnoses Axis I DSM-5: schizophrenic disorders or current psychotic episode or in the past, bipolar disorder, current major depressive disorder autism spectrum.
  • Abus Psychotropic substance dependency or a psychotropic substance, including alcohol (except nicotine).
  • Support Regular / chronic drugs and other xenobiotics tropic psychotropic.
  • Support Treatment with benzodiazepines in the 4 months prior to study entry. -Patient Subject to a measure of legal protection (guardianship, curatorship or safeguard justice). -No private freedom by administrative decision or justice.
  • No Unable to consent and are not subject to a protection measure.
  • Problems General understanding.
  • Weight Of more than 150 kg.
  • Inability To maintain an upper portion of movement of the body lying down for at least 10 minutes (frequency tics on YGTSS\> 3).
  • In healthy volunteers (HV):
  • psychiatric disorders, cognitive impairment assessed by the MINI scale.
  • About not being able to understand the tasks
  • age \<18 years.
  • No Subject to a measure of legal protection (guardianship, curatorship or safeguard justice).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HARTMANN

Paris, Île-de-France Region, 75013, France

Location

Related Publications (4)

  • Atkinson-Clement C, de Liege A, Klein Y, Beranger B, Valabregue R, Delorme C, Roze E, Fernandez-Egea E, Hartmann A, Robbins TW, Worbe Y. The sooner the better: clinical and neural correlates of impulsive choice in Tourette disorder. Transl Psychiatry. 2021 Nov 3;11(1):560. doi: 10.1038/s41398-021-01691-2.

    PMID: 34732691BACKGROUND
  • Atkinson-Clement C, Sofia F, Fernandez-Egea E, de Liege A, Beranger B, Klein Y, Deniau E, Roze E, Hartmann A, Worbe Y. Structural and functional abnormalities within sensori-motor and limbic networks underpin intermittent explosive symptoms in Tourette disorder. J Psychiatr Res. 2020 Jun;125:1-6. doi: 10.1016/j.jpsychires.2020.02.033. Epub 2020 Mar 4.

    PMID: 32169732BACKGROUND
  • Atkinson-Clement C, Porte CA, de Liege A, Wattiez N, Klein Y, Beranger B, Valabregue R, Sofia F, Hartmann A, Pouget P, Worbe Y. Neural correlates and role of medication in reactive motor impulsivity in Tourette disorder. Cortex. 2020 Apr;125:60-72. doi: 10.1016/j.cortex.2019.12.007. Epub 2019 Dec 30.

    PMID: 31978743BACKGROUND
  • Atkinson-Clement C, Porte CA, de Liege A, Klein Y, Delorme C, Beranger B, Valabregue R, Gallea C, Robbins TW, Hartmann A, Worbe Y. Impulsive prepotent actions and tics in Tourette disorder underpinned by a common neural network. Mol Psychiatry. 2021 Jul;26(7):3548-3557. doi: 10.1038/s41380-020-00890-5. Epub 2020 Sep 29.

    PMID: 32994553BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 10, 2016

Study Start

October 14, 2016

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

September 4, 2025

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations