Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study
COGIT
Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".
2 other identifiers
interventional
98
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
November 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2018
CompletedSeptember 4, 2025
August 1, 2021
1.5 years
October 27, 2016
August 28, 2025
Conditions
Keywords
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 COMPARATORcomportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients
UNTREATED PATIENT WITH TOURETTE SYNDROME
ACTIVE COMPARATORcomportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients
Healthy volunteers
PLACEBO COMPARATORcomportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects
Interventions
Eligibility Criteria
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
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: 34732691BACKGROUNDAtkinson-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: 32169732BACKGROUNDAtkinson-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: 31978743BACKGROUNDAtkinson-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
Condition Hierarchy (Ancestors)
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