Clinical trial NCT04837079: National Survey of Essential Tremor Plus in China
Official title: National Survey of Essential Tremor Plus in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Essential Tremor-plus
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are Han Chinese from mainland China.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Lack of capacity to consent to participate in the project

Primary outcomes:
measure: 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).
timeFrame: May 1, 2021-April 30, 2022
Secondary outcomes:
measure: The non-motor symptoms are evaluated by Non-motor Symptom Scale.
timeFrame: May 1, 2021-April 30, 2022
measure: Cognitive condition is assessed by Mini Mental State Examination (MMSE).
timeFrame: May 1, 2021-April 30, 2022
measure: Cognitive condition is assessed by Montreal Cognitive Assessment (MOCA).
timeFrame: May 1, 2021-April 30, 2022
measure: Tandem walk, Berg balance scale (BBS) and 10 meter walk timing test are used to evaluate balance and gait in ET-plus.
timeFrame: May 1, 2021-April 30, 2022
measure: The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus.
timeFrame: May 1, 2021-April 30, 2022
measure: The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus.
timeFrame: May 1, 2021-April 30, 2022
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: