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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in China

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.

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.

  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).

    Measured: May 1, 2021-April 30, 2022

Secondary outcomes (6)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted8 Apr 2021
  2. Study start1 May 2021 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

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
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

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.

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