National Survey of Essential Tremor Plus in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The tremor's impact on activities of daily living and clinical measurement of ET severity are evaluated by The Essential Tremor Rating Assessment Scale (TETRAS).
研究概览
简要总结
National Survey of Essential Tremor Plus in China（NSETP-China）is a multicenter cross-sectional study designed to investigate the clinical features of ET-plus in mainland China.
详细描述
Essential tremor (ET) is one of the most common adult-onset movement disorders, affecting 0.9% of the population across all ages worldwide. ET is a chronic, progressive neurologic disease whose the most recognizable clinical feature is a 4~12 Hz kinetic tremor of the upper limbs, usually occurring during a variety of voluntary movements. The etiology and pathogenesis of ET remain elusive.
Essential tremor-plus (ET-plus) is a new term coined in 2018 MDS consensus statement on tremor. ET-plus is defined as tremor with the characteristics of essential tremor, with additional neurological signs of uncertain clinical significance, such as impaired tandem gait, questionable dystonic posturing, memory impairment, or other mild neurological signs of unknown clinical significance that do not suffice to make an additional syndrome classification or diagnosis.
ET-plus is a controversial new concept. We will use scales or questionnaires to investigate the common soft neurological signs of ET-plus in mainland China. The details are as follows: (1) The tremor's impact on activities of daily living and clinical measurement of ET severity are evaluated by The Essential Tremor Rating Assessment Scale (TETRAS). (2) Cognitive condition is assessed by Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA). (3) The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS). (4) Clinical assessment of balance and gait in ET-plus: we will use Tandem walk, Berg balance scale (BBS) and 10 meter walk timing test. (5) The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus. (6) The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ET and/or ET-plus by the Consensus Statement on the Classification of Tremors, from the Task Force on Tremor of the International Parkinson and Movement Disorder Society.
排除标准
- •Lack of capacity to consent to participate in the project
结局指标
主要结局
The tremor's impact on activities of daily living and clinical measurement of ET severity are evaluated by The Essential Tremor Rating Assessment Scale (TETRAS).
时间窗: May 1, 2021-April 30, 2022
TETRAS consists of two subscales. The first one, Activities of Daily Living (ADL) Subscale contains 12 selfscored items, rating tremor's impact on ADL in a 0-4 Likert-type scale. Total score varies from 0-48. Higher score indicates a bigger impact on activities of daily living. The second part is the Performance Subscale, and is rated by clinicians'examination. The subscale is formed by 9 items that rate action tremor in the head, face, voice, limbs, and trunk from 0 to 4. Total score varies from 0-64. Higher score indicates severer tremor. For most items, the scores are defined only by whole numbers, but 0.5 increments may be used if you believe the rating is between two whole number ratings and cannot be reconciled to a whole number. Each 0.5 increment in rating is specifically defined for the assessment of upper limb postural and kinetic tremor and the dot approximation task (items 4 and 8).
次要结局
- Cognitive condition is assessed by Mini Mental State Examination (MMSE).(May 1, 2021-April 30, 2022)
- Cognitive condition is assessed by Montreal Cognitive Assessment (MOCA).(May 1, 2021-April 30, 2022)
- The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus.(May 1, 2021-April 30, 2022)
- The non-motor symptoms are evaluated by Non-motor Symptom Scale.(May 1, 2021-April 30, 2022)
- Tandem walk, Berg balance scale (BBS) and 10 meter walk timing test are used to evaluate balance and gait in ET-plus.(May 1, 2021-April 30, 2022)
- The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus.(May 1, 2021-April 30, 2022)