The Chinese Functional Movement Disorders Registry Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The symptom characteristics
研究概览
简要总结
The purpose of the Chinese Functional Movement Disorders Registry (FMDs-China) is to develop a database of patients with Functional Movement Disorders (FMDs) in China.
详细描述
Functional movement disorders (FMDs), also known as psychogenic movement disorders (PMDs), formerly known as "hysteria or hysteria", is a representative functional nervous system disease. It has been reported in Europe and America that FMDs patients account for 3% - 6% of all patients in the outpatient department of motor disorders, but there is no relevant data report in China so far. From the current research, the incidence rate has gradually increased significantly. However, the research about the pathogenesis and diagnosis of such diseases is rare. These studies have the problem of small sample size and still lack large randomized controlled studies to demonstrate the long-term efficacy of different treatments. And in China, there are nearly no reliable research and the lack of basic understanding makes it a "gray area" for the diagnosis and treatment of FMDs.
The purpose of this observational study is to prospectively register the information of patients with FMDs nationwide, establishing a Chinese multicenter FMDs China cohort; understanding the demographic characteristics, clinical characteristics and symptom characteristics, neuropsychological test, electrophysiological and imaging characteristics, drug use, etc. what's more, it lays a foundation for the research on the etiology and treatment in the second stage of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female;
- •Age 18-80;
- •Patients clinically diagnosed with functional movement disorders according to the Fahn-Williams criteria;
- •Patients who are willing to provide information such as disease history and cooperate with physical examination and examination;
排除标准
- •Patients with definite organic dyskinesia;
- •There are other causes of dyskinesia such as fatigue, pain, hyperthyroidism, chronic alcoholism, and drug use;
- •Those who suffer from serious physical diseases and are unable to cooperate;
- •Those who do not cooperate or refuse to sign informed consent.
结局指标
主要结局
The symptom characteristics
时间窗: 2 years
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
The movement disorder attack video
时间窗: 2 years
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
The Simplified Functional Movement Disorders Rating Scale
时间窗: 2 years
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
次要结局
- Hamilton Depression Scale(2 years)
- symptom check list-90(2 years)
- clinical global impression severity scale(2 years)
- Clinical global improvement scale(2 years)
- Beck Anxiety Inventory(2 years)