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临床试验/NCT04179435
NCT04179435已完成不适用

Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2019年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
Behavioral test main outcome measures [4]

研究概览

简要总结

In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.

详细描述

Thus, the aims of the present project is threefold:

Aim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.

To achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.

Aim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.

Aim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Tourette syndrome
  • Ages 13 - 18
  • Acceptance to perform the Brain MRI
  • Acceptance to perform the cognitive testing
  • Acceptance to perform the TMS measures

排除标准

  • Learning disability
  • Incompatibility with MRI procedure (metal body implants, pregnancy)

研究组 & 干预措施

Tourette syndrome

Other

Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures

干预措施: brain MRI (Other)

Tourette syndrome

Other

Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures

干预措施: Behavioral testing on cognitive computerized tasks (Behavioral)

Tourette syndrome

Other

Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures

干预措施: TMS (Other)

Controls

Other

Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures

干预措施: Behavioral testing on cognitive computerized tasks (Behavioral)

Controls

Other

Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures

干预措施: brain MRI (Other)

Controls

Other

Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures

干预措施: TMS (Other)

结局指标

主要结局

Behavioral test main outcome measures [4]

时间窗: from 16 to 20 months

agency composite scores

Behavioral test main outcome measures [2]

时间窗: from 16 to 20 months

discounting factor

Behavioral test main outcome measures [3]

时间窗: from 16 to 20 months

number of premature responses

Brain MRI scan measures

时间窗: from 16 to 20 months

whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology

Behavioral test main outcome measures [1]

时间窗: from 16 to 20 months

reaction times

Transcranial magnetic stimulation

时间窗: from 16 to 20 months

Short Intracortical Inhibition (SICI) scores

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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