Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in signal intensity measured during EEG recording
研究概览
简要总结
The purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms.
详细描述
This study will:
- Explore effects of TMS and tDCS on movement intention.
- Discern the neural activity underlying modulation of movement intention with neuroimaging recording.
- Identify brain stimulation's effect in patients with psychogenic tremor and non-epileptic seizures.
- Technical development of new experimental paradigms and data analysis methods.
- Data collection for hypotheses development.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Healthy Controls)
- •Fluent in English
- •(Patients with PMD or PNES):
- •Diagnosis of PMD/PNES confirmed by a neurologist with expertise in movement disorders.
- •Per the treating neurologist, subject is unlikely to require treatment and/or dosage changes for 3-6 months following screening
排除标准
- •Any history of a significant neurological disorder, which may interfere with the interpretation of study data, as determined by the PI
- •Chronic or progressive medical condition
- •Any history of traumatic brain injury or significant head trauma
- •Currently meets criteria for substance abuse or dependence
- •History of any psychotic disorder or other psychiatric condition which may interfere with data interpretation
- •Pregnancy
- •Metal or devices in the head, including neurostimulators or metal foreign bodies
- •Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.
- •Any other ferromagnetic substance in the body that may increase study risk (including dental prosthetics, etc.).
- •Taking tricyclic antidepressant or antiepileptic medications or CNS active drugs under "strong potential hazard" list in Rossi et al., 2009
- •Current diagnosis of any inflammatory or autoimmune disorder within last 6 months
- •PMD and PNES Patients
- •Any history of traumatic brain injury or significant head trauma
- •Diagnosis of organic seizure disorder, including febrile seizures and tonic-clonic seizures;
- •Neurological disorder other than PMD and PNES including stroke, fainting spells or syncope of unknown cause(s);
- •Major or unstable medical illness, especially any current diagnosis of inflammatory or autoimmune disorders within last 6 months
- •Metal or devices in the head, including neurostimulators or metal foreign bodies
- •Taking tricyclic antidepressant medications or CNS active drugs under "strong potential hazard" list in Rossi et al., 2009;
- •Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) ≤24;
- •Recurrent visual hallucinations, within the past 6 months;
- •History of significant uncontrollable movements of the head;
- •Any clinically significant abnormality on vital signs
研究组 & 干预措施
Healthy Patients
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
干预措施: rTMS of left or right angular gyrus (AG) or frontal cortex (FC) (Device)
Healthy Patients
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
干预措施: Anodal tDCS of left or right AG or FC (Device)
PMD/PNES patients
PMD and PNES subjects will be referred by the treating
干预措施: rTMS of left or right angular gyrus (AG) or frontal cortex (FC) (Device)
PMD/PNES patients
PMD and PNES subjects will be referred by the treating
干预措施: Anodal tDCS of left or right AG or FC (Device)
Healthy Patients
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
干预措施: Sham TMS3 stimulation (Device)
PMD/PNES patients
PMD and PNES subjects will be referred by the treating
干预措施: Sham TMS3 stimulation (Device)
结局指标
主要结局
Changes in signal intensity measured during EEG recording
时间窗: 3 Hours
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured during MEG
时间窗: 3 Hours
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured using of tDCS
时间窗: 30 Minutes
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
次要结局
未报告次要终点