Essential Tremor-plusNCT04837079
National Survey of Essential Tremor Plus in China
An observational study of Essential Tremor-plus, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Tremor-plus
- What is being tested?
- Clinical observational study
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Apr 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are Han Chinese from mainland China.
Who may be able to join
- 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.
Who cannot join
- Lack of capacity to consent to participate in the project
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
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.
Read the 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.
- Conditions
- Essential Tremor-plus
- Being tested
- Clinical observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical observational studyOther
Clinical observational study
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 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).
Measured: May 1, 2021-April 30, 2022
Secondary outcomes (6)
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: May 1, 2021-April 30, 2022
Cognitive condition is assessed by Mini Mental State Examination (MMSE).
MMSE 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 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: May 1, 2021-April 30, 2022
Cognitive condition is assessed by Montreal Cognitive Assessment (MOCA).
MOCA scale is a one page 30 point test. 16 items and 11 categories to assess multiple cognitive domains, including short-term memory recall task, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation to time and place. A cutoff 26 is used to define cognitive impairment. 1 point is added to the test-taker's score if they have 12 years education or less.
Measured: 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.
Tandem walk:In this test, patients are asked to walk 10 steps on a straight path, with the heel of the leading foot touching the toe of the following foot. The number of missteps, defined as the number of steps away from the straight-line path, is the primary outcome reported. Balance is assessed by Berg Balance (BBS). The total score of the this scale is 56. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. 0" indicates the lowest level of function and "4" the highest level of function. 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance. Walking condition is assessed by 10 metre Walk Test (10 MWT). Patients walk without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration.
Measured: May 1, 2021-April 30, 2022
The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus.
Dystonia postural is assessed by revised Dystonia Rating Scales (UDRS). The total score of this scale is 112, includes ratings for 7 items. For each of the items assessed, the UDRS has a severity and a duration rating. The severity rating is specific for each body region assessed and ranges from 0 (no dystonia) to 4 (extreme dystonia). The Duration rating assesses whether dystonia occurs at rest or with action, and whether it is predominantly at maximal or sub maximal intensity. The total score for the UDRS is the sum of the severity and duration factors.
Measured: May 1, 2021-April 30, 2022
The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus.
SARA has eight items that yield a total score of 0 (no ataxia) to 40 (most severe ataxia); 1: gait (score 0 to 8), 2: stance (score 0 to 6), 3: sitting (score 0 to 4), 4: speech disturbance (score 0 to 6), 5: finger chase (score 0 to 4), 6: nose-finger test (score 0 to 4), 7: fast alternating hand movements (score 0 to 4), 8: heel-shin slide (score 0 to 4). Limb kinetic functions (items 5 to 8) are rated independently for both sides, and the arithmetic mean of both sides is included in the SARA total score.
Measured: May 1, 2021-April 30, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Tremor-plusStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
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
- NCT04837079
- Sponsor's protocol ID
- NSETP-China
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey of Essential Tremor Plus in China
- ClinicalTrials.gov ID
- NCT04837079
- Acronym / sponsor ID
- NSETP-China
- Conditions
- Essential Tremor-plus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are Han Chinese from mainland China.
Key inclusion criteria (1 listed)
- 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.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical observational studyClinical observational study | Other | – |
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: May 1, 2021-April 30, 2022
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).
6 secondary outcomes
The non-motor symptoms are evaluated by Non-motor Symptom Scale.
Time frame: May 1, 2021-April 30, 2022
Cognitive condition is assessed by Mini Mental State Examination (MMSE).
Time frame: May 1, 2021-April 30, 2022
Cognitive condition is assessed by Montreal Cognitive Assessment (MOCA).
Time frame: 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.
Time frame: May 1, 2021-April 30, 2022
The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus.
Time frame: May 1, 2021-April 30, 2022
The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus.
Time frame: May 1, 2021-April 30, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-plus, 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: May 1, 2021-April 30, 2022). 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 8 Apr 2021.