- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02960698
Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study (COGIT)
Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ILE DE France
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Paris, ILE DE France, France, 75013
- HARTMANN
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
|
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
|
|
Placebo Comparator: Healthy volunteers
comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
behavior performance (percentage of correct responses and reaction time)
Time Frame: up to one month
|
up to one month
|
BOLD signal of functional MRI scan
Time Frame: up to one month
|
up to one month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
- Impulsive Behavior
Other Study ID Numbers
- C16-07
- 2016-A00936-45 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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