- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04198246
Chinese ET Registry (CETR)
The Chinese Essential Tremor Registry
Study Overview
Status
Conditions
Detailed Description
Essential tremor (ET) is one of the most common movement disorders and affects approximately 1% of the population worldwide. Twin and family history studies show a high heritability for essential tremor. The molecular genetic determinants of essential tremor are unknown. Some mutations have been found in ET families but have not been validated in others. The pathophysiological basis of ET remains unknown. In 2017, a task force of the International Parkinson and Movement Disorder Society proposed a new formal definition of essential tremor as a syndrome of isolated tremor of both upper limbs with a duration of at least 3 years, with or without tremor in other locations, such as head, larynx (voice tremor), or lower limbs. Defining essential tremor as a syndrome and not as a single disease, while concomitantly narrowing its phenotypic scope to increase its homogeneity, recognizes that there are multiple possible causes, which may facilitate progress in understanding the pathogenesis. Investigators aim to establish a database of longitudinal recruited ET cohort, and characterize the clinical feature, genetic basis, environmental factors and their interactions among different ET subtypes in China, identify natural history of a highly-presentative Chinese ET cohort and to discern major milestones in the disease process which indicates disease progression.
Data were collected at baseline. Information about detailed disease history, level of education, significant chronic comorbidities, physical examination, medication history, family history, living habits and toxic exposure history, which include smoking, drinking tea, alcoholic consumption, drinking coffee, exposure to pesticide or occupational solvent, history of carbon monoxide poisoning and recurrent head trauma will be recorded at baseline. For each evaluation, the same questionnaires will be conducted. A standardized neurological assessment according to the recommendation of Consensus on the construction of clinical database of Parkinson's disease and movement disorders in China.
The Essential Tremor Rating Assessment Scale (TETRAS) includes both performance and Activities of Daily Living (ADL) subscales. It is conducted for the clinical measurement of ET severity and tremor's impact on ADL. The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS).Functional constipation was diagnosed by the Rome III diagnostic criteria. Excessive daytime sleepiness was evaluated by Epworth Sleepiness Scale (ESS). Probable rapid eye movement sleep behavior disorder (p-RBD) was diagnosed by rapid eye movement sleep behavior questionnaire-Hongkong (RBDQ-HK). Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire (CH-RLSq). Cognitive assessment was used the previously validated scale, Mini Mental State Examination (MMSE). Olfaction test was carried out by Hyposmia Rating Scale (HRS), a proportion of patients was also ascertained by Sniffin's Sticks. Depression was diagnosed by Hamilton Depression Scale (HAMD).DNA samples extracted from peripheral blood and all the ET patients will be examed by Whole Exome Sequencing or Whole-genome sequencing. All the participants are scanned by structural MRI to exclude obvious intracranial lesions and other metabolic disorders, etc.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Qiying Sun, Ph.D
- Phone Number: +8615874907260
- Email: sunqiying2015@163.com
Study Contact Backup
- Name: Beisha Tang, MD
- Phone Number: +8613974856709
- Email: bstang7398@163.com
Study Locations
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Hunan
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Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital of Central South University
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Contact:
- Qiying Sun, Ph.D
- Phone Number: +8615874907260
- Email: sunqiying2015@163.com
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Contact:
- Jifeng Guo, Ph.D
- Phone Number: +8613974936815
- Email: guojifeng2003@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with ET 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: baseline
|
TETRAS consists of two subscales.
The first one, Activities of Daily Living (ADL) Subscale contains 12 self-scored 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).
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baseline
|
The non-motor symptoms are evaluated by Non-motor Symptom Scale.
Time Frame: baseline
|
This scale includes 30 items which is divided into 9 domains.
Total score varies from 0-360.
Higher score indicates severer symptoms.
Domain 1 evaluates cardiovascular system symptoms.
Score of domain 1 varies from 0-24.
Domain 2 evaluates sleep condition.
Score of domain 2 varies from 0-48.
Domain 3 evaluates cognitive function.
Score of domain 3 varies from 0-72.
Domain 4 evaluates illusion.
Score of domain 4 varies from 0-36.
Domain 5 evaluates attention and memory.
Score of domain 5 varies from 0-36.
Domain 6 evaluates gastrointestinal symptoms.
Score of domain 6 varies from 0-36.
Domain 7 evaluates urinary symptoms.
Score of domain 7 varies from 0-36.
Domain 8 evaluate sensory symptoms.
Score of domain 8 varies from 0-24.
Domain 9 evaluates other non-motor symptoms.
Score of domain 9 varies from 0-48.
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baseline
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Cognitive condition is assessed by Mini Mental State Examination.
Time Frame: baseline
|
This scale includes 30 items.
Score of all the questions will be summed.
All items were rated on a 2-point scale (0-1), with a minimal score of 0, and maximum total score of 30.
A higher score demonstrates more better cognitive condition.
The definition of cognitive disorder differs in education level.
For illiteracy, presence of cognitive impairment is defined as MMSE score.
For those only receive elementary education, the cut-off value is 20.
For other patients, presence of cognitive impairment was defined as MMSE scores less than 25.
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baseline
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Olfaction test was measured by Hyposmia Rating Scale.
Time Frame: baseline
|
This scale includes 6 items.
Score of all the questions will be summed.
All items were rated on a 4-point scale (1-4), with a minimal score of 6, and maximum total score of 24.
A higher score demonstrates more worse sense of olfaction.
The cutoff value HRS is 22.5.
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baseline
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Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale.
Time Frame: baseline
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This scale includes 17 items.
Score of all the questions will be summed.
Total score ranges from0-53.
A higher score demonstrates more severer depression.
The study participants were defined to be not depressed (scores 0-6), to have minor depression (scores 7-14), or to have major depression (scores above 14) at the different visits during follow-up.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III.
Time Frame: baseline
|
The diagnostic criteria must include two or more of the following:
Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. |
baseline
|
Excessive sleepiness is evaluated by Epworth Sleepiness Scale.
Time Frame: baseline
|
This scale includes 8 items.
Score of all the questions will be summed.
All items were rated on a 4-point scale (0-3), with a minimal score of 0, and maximum total score of 24.
A higher score demonstrates more severe excessive daytime sleepiness.
Participants were classified as showing excessive daytime sleepiness if their total score ≥10.
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baseline
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Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire-Hongkong.
Time Frame: baseline
|
This scale includes 13 items.
Score of all the questions will be summed.
Total score of the answers ranges from 0 to 100, where higher scores reflect severer rapid eye movement sleep behavior disorder.
The optimal cutoff value for the overall scale is 17; subjects were classified as showing RBD when they reached the above score.
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baseline
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Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire.
Time Frame: baseline
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|
baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CETR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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