COGIT: Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT02960698

Collaborator

(none)

Enrollment

Location

Arms

18.3

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome	Other: IRM and comportemental tasks	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".

Actual Study Start Date :

Oct 14, 2016

Actual Primary Completion Date :

Apr 24, 2018

Actual Study Completion Date :

Apr 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TREATED PATIENT WITH TOURETTE SYNDROME comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients	Other: IRM and comportemental tasks
Active Comparator: UNTREATED PATIENT WITH TOURETTE SYNDROME comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients	Other: IRM and comportemental tasks
Placebo Comparator: Healthy volunteers comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects	Other: IRM and comportemental tasks

Arm

Intervention/Treatment

Active Comparator: TREATED PATIENT WITH TOURETTE SYNDROME

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

Other: IRM and comportemental tasks

Active Comparator: UNTREATED PATIENT WITH TOURETTE SYNDROME

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

Other: IRM and comportemental tasks

Placebo Comparator: Healthy volunteers

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

Other: IRM and comportemental tasks

Outcome Measures

Primary Outcome Measures

behavior performance (percentage of correct responses and reaction time) [up to one month]
BOLD signal of functional MRI scan [up to one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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