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Clinical Trials/NCT02960698
NCT02960698
Completed
Not Applicable

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

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country98 target enrollmentOctober 14, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
98
Locations
1
Primary Endpoint
BOLD signal of functional MRI scan
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2016
End Date
April 24, 2018
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

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

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.

Outcomes

Primary Outcomes

BOLD signal of functional MRI scan

Time Frame: up to one month

behavior performance (percentage of correct responses and reaction time)

Time Frame: up to one month

Study Sites (1)

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