Essential TremorNCT04198246
Chinese ET Registry (CETR)
An observational study of Essential Tremor, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The purpose of the Chinese Essential Tremor Registry (CETR) is to develop a database of patients with Essential tremor in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Tremor
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Lack of capacity to consent to participate in the project.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Qiying Sun, Ph.D, +8615874907260, sunqiying2015@163.com
Jifeng Guo, Ph.D, +8613974936815, guojifeng2003@163.com
About this study
Official title: The Chinese Essential Tremor Registry
The purpose of the Chinese Essential Tremor Registry (CETR) is to develop a database of patients with Essential tremor in China.
Read the 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.
- Conditions
- Essential Tremor
- Keywords
- Motor symptoms, Nonmotor symptoms, Natural history, The Essential Tremor Rating Assessment Scale (TETRAS)
- Medical subject headings
- Essential Tremor
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (4)
Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III.
The diagnostic criteria must include two or more of the following:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three defecations per week 2. Loose stools are rarely present without the use of laxatives 3.
Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Measured: baseline
Excessive sleepiness is evaluated by Epworth Sleepiness Scale.
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.
Measured: baseline
Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire-Hongkong.
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.
Measured: baseline
Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire.
- have, or have you had, recurrent uncomfortable feelings or sensations in your legs while you are sitting or lying down
- have, or have you had, a recurrent need or urge to move your legs while you were sitting or lying down
- more likely to have these feelings when you are resting
- If you get up or move around when you have these feelings, these feelings get better
- these feelings in your legs most likely to occur at mid-day or afternoon or evening or night
- Simply changing leg position by itself once without continuing to move usually relieve these feelings usually don't relieves
- These feelings are not or not always due to muscle cramps
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198246
- Sponsor's protocol ID
- CETR
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Essential Tremor Registry
- ClinicalTrials.gov ID
- NCT04198246
- Acronym / sponsor ID
- CETR
- Conditions
- Essential Tremor
- Keywords
- Motor symptoms, Nonmotor symptoms, Natural history, The Essential Tremor Rating Assessment Scale (TETRAS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Chinese Essential Tremor Registry (CETR) is to develop a database of patients with Essential tremor in China.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack of capacity to consent to participate in the project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
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.
Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale.
Time frame: baseline
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.
4 secondary outcomes
Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III.
Time frame: baseline
Excessive sleepiness is evaluated by Epworth Sleepiness Scale.
Time frame: baseline
Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire-Hongkong.
Time frame: baseline
Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiying Sun, Ph.D (+8615874907260, sunqiying2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.