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