Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study (NCT02960698) | Clinical Trial Compass
CompletedNot Applicable
Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study
France98 participantsStarted 2016-10-14
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
behavior performance (percentage of correct responses and reaction time)
Timeframe: up to one month
2
BOLD signal of functional MRI scan
Timeframe: up to one month
Trial details
NCT IDNCT02960698
SponsorInstitut National de la Santé Et de la Recherche Médicale, France