Chinese ET Registry (CETR)

NCT04198246 | Recruiting

• 1 other identifier: CETR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the Chinese Essential Tremor Registry (CETR) is to develop a database of patients with Essential tremor in China.

Conditions

Essential Tremor

Keywords

Motor symptoms; Nonmotor symptoms; Natural history; The Essential Tremor Rating Assessment Scale (TETRAS)

Outcome Measures

Primary Outcomes (5)

• 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 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).

  baseline

• The non-motor symptoms are evaluated by Non-motor Symptom Scale.

  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.

  baseline

• Cognitive condition is assessed by Mini Mental State Examination.

  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.

  baseline

• Olfaction test was measured by Hyposmia Rating Scale.

  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.

  baseline

• Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale.

  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.

  baseline

Secondary Outcomes (4)

• Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III.

  baseline

• Excessive sleepiness is evaluated by Epworth Sleepiness Scale.

  baseline

• Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire-Hongkong.

  baseline

• Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire.

  baseline

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Most of the ET patients comes from mainland China, especially from Hunan Province, Hubei Province, Jiangxi Province and Guizhou Province. The proportion of male patients is slightly dominant than that of female patients. The age of ET patients ranges from 13 to more than 90 years old.

You may qualify if:

• 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.

You may not qualify if:

• Lack of capacity to consent to participate in the project.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Extraction of DNA from peripheral blood of patients.

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Qiying Sun, Ph.D

CONTACT

+8615874907260; sunqiying2015@163.com

Beisha Tang, MD

CONTACT

+8613974856709; bstang7398@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

CN (1)