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Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study (COGIT)

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IRM and comportemental tasks
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 other trial for Tourette Syndrome focused on measuring cognitive impulsivity, IRM, Tourette Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
  • No psychotropic treatments (neuroleptics, antidepressants or anxiolytics) mentioned at the time of inclusion.
  • 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

Exclusion Criteria:

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.
  • Participation In other biomedical research or subjected to an exclusion period for another search.
  • 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).
  • Participation In other biomedical research or subjected to an exclusion period for another search.
  • Not Unable to consent and are not subject to a protection measure.
  • Not private freedom by administrative decision or court

For TS patients (treated and untreated) and HV

  • relative to MRI 3Tesla : pacemaker, cardiac cell or neural stimulator ferromagnetic surgical clips body intraocular or intracranial metallic foreign cochlear implant artificial heart valve or arterial metal surgical equipment metallic material that could concentrate the radio frequency pulses pregnant women, women in labor or lactating aneurism Standing up the eyelids vascular malformation of the brain
  • Topic not wishing to be informed of a clinically significant abnormality discovered during the realization of MRI

Sites / Locations

  • HARTMANN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

TREATED PATIENT WITH TOURETTE SYNDROME

UNTREATED PATIENT WITH TOURETTE SYNDROME

Healthy volunteers

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

behavior performance (percentage of correct responses and reaction time)
BOLD signal of functional MRI scan

Secondary Outcome Measures

Full Information

First Posted
October 27, 2016
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02960698
Brief Title
Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study
Acronym
COGIT
Official Title
Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)

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

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
cognitive impulsivity, IRM, Tourette Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREATED PATIENT WITH TOURETTE SYNDROME
Arm Type
Active Comparator
Arm Description
comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients
Arm Title
UNTREATED PATIENT WITH TOURETTE SYNDROME
Arm Type
Active Comparator
Arm Description
comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients
Arm Title
Healthy volunteers
Arm Type
Placebo Comparator
Arm Description
comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects
Intervention Type
Other
Intervention Name(s)
IRM and comportemental tasks
Primary Outcome Measure Information:
Title
behavior performance (percentage of correct responses and reaction time)
Time Frame
up to one month
Title
BOLD signal of functional MRI scan
Time Frame
up to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 No psychotropic treatments (neuroleptics, antidepressants or anxiolytics) mentioned at the time of inclusion. 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 Exclusion Criteria: 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. Participation In other biomedical research or subjected to an exclusion period for another search. 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). Participation In other biomedical research or subjected to an exclusion period for another search. Not Unable to consent and are not subject to a protection measure. Not private freedom by administrative decision or court For TS patients (treated and untreated) and HV relative to MRI 3Tesla : pacemaker, cardiac cell or neural stimulator ferromagnetic surgical clips body intraocular or intracranial metallic foreign cochlear implant artificial heart valve or arterial metal surgical equipment metallic material that could concentrate the radio frequency pulses pregnant women, women in labor or lactating aneurism Standing up the eyelids vascular malformation of the brain Topic not wishing to be informed of a clinically significant abnormality discovered during the realization of MRI
Facility Information:
Facility Name
HARTMANN
City
Paris
State/Province
ILE DE France
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study

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