Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- BOLD signal of functional MRI scan
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
BOLD signal of functional MRI scan
时间窗: up to one month
behavior performance (percentage of correct responses and reaction time)
时间窗: up to one month
次要结局
未报告次要终点