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临床试验/NCT03681795
NCT03681795招募中不适用

Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Correlation coefficients

研究概览

简要总结

Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear.

详细描述

Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear. It would involve an alteration of striatal-cortico-thalamic cortical circuits resulting in dopaminergic dysfunction. But glutamatergic hypothesis is also discussed from pharmacological, biochemical and genetic arguments. Exploration of glutamatergic system can be done in humans in vivo using a new radiotracer: the [18F] FNM (Fluoroethylnormemantine), a derivative of memantine. In the present study, aim of the study 1) to show the glutamatergic system "in vivo" in patients with Tourette's syndrome and 2) to perform correlations between various motor and behavioral symptoms and the pattern of brain fixation for this radiotracer. To do that, a pilot study will be conducted in 12 patients with Tourette's who will be evaluated in terms of motor (tics) and behavioral (OCD, anxiety, depression, impulsivity) symptoms. Each patient will have a PET-scan exam and a brain MRI exam. Data analysis will be carried out from two different approaches: first by region of interest, and secondly, without topographic a priori with the Statistical Parametric Mapping (SPM) software.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gilles de la Tourette syndrome according to the American Psychiatric association criteria (5 th ed, American Psychiatric association (APA), 2013)
  • Aged 18 and over
  • Patients treated with 2nd-generation neuroleptics for at least 3months
  • Signed consent form

排除标准

  • contraindications for MRI exam
  • claustrophobia
  • person under exclusive period for another study
  • pregnant women
  • patients under non-authorized treatment (1rst generation neuroleptics) or non-treated by neuroleptics

结局指标

主要结局

Correlation coefficients

时间窗: Day 1

Correlation coefficients is determined between the fixation of the PET tracer and the Total Tic score (TTS - from 0 to 50) which reflects the severity of tics in patients (under the Yale Global Tic Severity Scale - YGTSS)(Leckman and al, 1989).

次要结局

  • Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II(Day 1)
  • Barrat Impulsivity Scale 11(Day 1)
  • Yale Global Tic Severity Scale (YGTSS)(Day 1)
  • Hospital Anxiety Depression(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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