National Survey of Essential Tremor Plus in China
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedApril 8, 2021
April 1, 2021
12 months
April 5, 2021
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (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).
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).
May 1, 2021-April 30, 2022
Secondary Outcomes (6)
The non-motor symptoms are evaluated by Non-motor Symptom Scale.
May 1, 2021-April 30, 2022
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
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
- +1 more secondary outcomes
Interventions
Clinical observational study
Eligibility Criteria
Patients are Han Chinese from mainland China.
You may qualify if:
- 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.
You may not qualify if:
- Lack of capacity to consent to participate in the project
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
May 1, 2021
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
April 8, 2021
Record last verified: 2021-04