Neurobiological Studies of Functional Movement Disorders and Non-Epileptic Seizures
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 4
- 主要终点
- Genetics: S/S genotype of the serotonin transporter promoter region polymorphism.
研究概览
简要总结
This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital.
Healthy volunteers and people with functional movement disorders (FMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study.
Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking.
Patients with FMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen.
Healthy volunteers may have blood drawn for genetic testing or fMRI or both.
详细描述
Objectives:
The study investigates the neurobiological correlates of conversion disorder (CD). The primary objectives are to investigate in CD patients:
- The role of emotional valence in an implicit emotional processing task (COMPLETE)
- The frequency of the 5HTTLPR S/S genotype
- Structural differences in grey matter of the brain as detected by voxel-based morphometry (VBM)
- The neural correlates of fear conditioning and fear extinction in a fear learning fMRI task
- The neural correlates of interoceptive activity in a Interoceptive Attention fMRI task
- Identifying the cortical physiology correlated with making a movement following a go command.
- Identifying the cortical physiology correlated with not making a movement following a no-go command.
- Identifying the cortical physiology correlated with planning to move or not move following a choose go-no go command.
Exploratory objectives are to investigate in CD patients:
- The frequency of several gene polymorphisms that are implicated in stress and affective disorder, including 5HTTLPR S/S (serotonin receptor), COMT (catechol-o-methyltransferase enzyme), Val/Met BDNF (brain-derived neurotrophic factor) and FKBP5 rs1360780 genotypes, as well as other polymorphisms or mutations to be determined later. Additionally, epigenetic data will be explored.
- The levels of salivary cortisol as a measure of stress.
- The heart rate variability, as a measure of autonomic nervous system function. (COMPLETE)
- Structural differences in white matter of the brain as detected by diffusion tensor imaging (DTI)
- The resting state BOLD fMRI signal
- The impact of the caregiver's attitude on the patients' symptoms
- The relationship between hemodynamic responses in regions implicated in interoception and self-reported measures of interoceptive attention, as well as behavioral and motor symptom severity
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Genetics: S/S genotype of the serotonin transporter promoter region polymorphism.
时间窗: throughout
The S/S genotype of the 5HTTLPR polymorphism
fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task
时间窗: throughout
fMRI BOLD signal change focusing on regions of interest during emotional valence task
Anatomical MRI: VBM
时间窗: throughout
Structural grey matter brain data
次要结局
未报告次要终点