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Essential TremorNCT06349538

Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor

An observational study of Essential Tremor, run by Medical University of Graz at 1 site in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this observational study is to learn about epidemiology, biologic markers, disease subtypes and possible prognostic factors in essential tremor (ET) patients. The main question[s] it aims to answer are: The prevalence of ET-plus compared to ET in a prospectively collected ET population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Tremor
What is being tested?
Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.
How many people
100 participants
Where
1 siteAustria
Study dates
4 Apr 2024to 30 Apr 2034
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: ET-patients will be recruited from all patients visiting a tertiary neurological hospital and its various institutions (emergency department, outpatient clinic, specialised outpatient clinic for movement disorders, ward patients) for any neurologic complaint.

Who may be able to join

  • Presence of an essential tremor syndrome according to MDS consensus criteria or suspected incipient essential tremor (differential diagnosis vs. enhanced physiological tremor)
  • Patient is able and willing to give informed consent.
  • age above 18 years.

Who cannot join

  • Patient is not able or not willing to give informed consent.
  • Existence of a legal representative.
  • age below 18 years

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Graz

    Graz, Austria, 8036

Other trials in Austria

About this study

Official title: Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor - a Prospective Cohort Study

The goal of this observational study is to learn about epidemiology, biologic markers, disease subtypes and possible prognostic factors in essential tremor (ET) patients. The main question[s] it aims to answer are:

  • The prevalence of ET-plus compared to ET in a prospectively collected ET population.
  • To assess in detail the heterogenous group of ET patients using comprehensive clinical (motor and non-motor scales, questionnaires), imaging [magnetic resonance imaging (MRI), sonography of substantia nigra and cerebral vessels], neurophysiological (tremor analysis, digital spiral drawing) and laboratory markers (sGFAP, sNfL, routine laboratory parameters).
  • To assess possible non-invasive markers of neurodegeneration in ET patients (optic coherence tomography, alpha-synuclein in olfactory mucosa)
Read more

Participants will be asked to undergo the above mention evaluation at baseline and at follow-up approx. 5 years later.

Researchers will compare the findings within the ET group to independently existing cohorts of healthy controls and/or patients with other movement disorders like Parkinson's disease.

Being tested
Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.
Keywords
essential tremor, subtypes, neurodegeneration, biomarkers, MRI, imaging, sGFAP, sNfL, tremor analysis
Medical subject headings
Essential Tremor, Nerve Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.Diagnostic test

    see previous descriptions

Study groups in NCT06349538
Study groupRoleWhat they receive
Essential tremor patientsEssential tremor patients will undergo a detailed clinical examination incl. motor/non motor scoring systems and questionnaires, blood draw, sonography, tremor analysis and cerebral MRI. Additionally, essential tremor patients will undergo optic coherence tomography and olfcatory mucosa swab for alpha-synuclein. All tests are conducted at baseline as well as at a follow-up examination 5 years later. No drugs or other interventions are to be administered
Receives: Diagnostic Test: Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of ET-plus

    Determine the prevalence of ET-plus within a prospectively collected ET population

    Measured: approx. 2 years

Secondary outcomes (57)

  1. Age of ET patients

    age at disease onset and age at baseline

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  2. Sex of ET patients

    male, female, other

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  3. Family history

    positive or negative for essential tremor or Parkinson's disease

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  4. Symptom leading to ET-plus classification

    e.g. rest tremor, impaired tandem gait, mild parkinsonian signs, questionable dystonia, mild cognitive impairment

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  5. current and former medication for essential tremor

    e.g. propranolol yes vs no, topiramate yes vs no, primidone yes vs no

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  6. subjective disease course of ET

    no progression, slowly and continuously, relapsing, plateau-like after initial progression, rapidly progressive

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  7. responsivity to alcohol

    amelioration of tremor severity after consumption of alcohol (yes vs. no vs. unknown)

    Measured: 1 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  8. presence of cardiovascular risk factors

    arterial hypertension yes vs. no, hyperlipidemia yes vs. no, smoking yes vs. no vs. former, diabetes mellitus yes vs. no, coronary artery disease yes vs. no

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  9. MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) parts I-IV

    rates clinical severity of parkinsonian symptoms, range 0-260 points with higher points meaning more severe symptoms

    Measured: 20-30 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  10. modified Essential Tremor Rating Assessment Scale (mTETRAS)

    rates clinical severity of ET symptoms, ranging from 0-80 (the "modified" means the inclusion of 2 additional items rating rest tremor) with higher points meaning more severe motor symptoms; also includes a subscale rating activities of daily living ranging from 0-48 points with more points meaning more severe disability due to ET

    Measured: 10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  11. Scale for the assessment and rating of ataxia (SARA)

    assesses symptoms of ataxia, ranging from 0 (no ataxia) to 40 (most severe ataxia)

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  12. Verbal fluency animals (part of the CERAD-plus test battery)

    patients needs to say as many animals as possible within 1 minute, the more, the better

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  13. Boston Naming Test (part of the CERAD-plus test battery)

    the patient needs to name 15 items (shown as pictures) correctly, the more, the better

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  14. Mini Mental State Examination Test (MMSE; part of the CERAD-plus test battery)

    a cognitive screening test with a minimum of 0 and a maximum of 30 points

    Measured: 3-5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  15. word list learning (part of the CERAD-plus test battery)

    the patient is shown 10 words which he needs to remember and repeat immediately after reading them (within 90 seconds); there a three tries; the more he remembers, the better

    Measured: 10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  16. constructive praxis (part of the CERAD-plus test battery)

    the patient needs to draw 4 figures from a model which are then rated according to prespecified criteria (maximum of 11 points, the more the better)

    Measured: 20-30 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  17. word list recall (part of the CERAD-plus test battery)

    the patient needs to remember as many of the 10 words learned in "word list learning"; time limit 90 seconds

    Measured: 90 seconds; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  18. word list recognition (part of the CERAD-plus test battery)

    the patient needs decide whether a word shown to him was part of the 10 words learned before; there a 20 words in total, and 10 each were part of the learned words while 10 where not; the more he/she remembers correctly, the better (1 point for each correctly identified word)

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  19. constructive praxis recall (part of the CERAD-plus test battery)

    the patients needs to draw the 4 figures from "constructive praxis" from memory; they are then rated according to the same criteria with a maximum of 11 points

    Measured: 3-4 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  20. Trail Making Test A (part of the CERAD-plus test battery)

    the patient needs to connect numbers in ascending order from 1 to 25, time is measured in seconds (the faster, the better)

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  21. Trail Making Test B (part of the CERAD-plus test battery)

    the patient needs to connect numbers and letters in ascending and alternating order from 1 to 13 and A to L, respectively, time is measured in seconds (the faster, the better)

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  22. s-words (part of the CERAD-plus test battery)

    the patient needs to list as many words starting with the letter "s" within 60 seconds as possible; the more the better

    Measured: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  23. Frontal Assessment Battery (FAB)

    a neuropsychological test focusing on executive function, ranging from 0 (most impaired) to 18 (normal)

    Measured: 5 - 10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  24. Geriatric Depression Scale (GDS)

    a short questionnaire rating depressive symptoms, ranging from 0 (no depressive symptoms) to 15 (most severe depressive symptoms)

    Measured: 3-5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  25. Hospital Anxiety and Depression Scale (HADS)

    a questionnaire rating anxiety and depressive symptoms, ranging from 0 (no depressive/anxious symptoms) to 42 (most severe symptoms)

    Measured: 5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  26. Non-Motor Symptoms Scale for Parkinson's Disease (NMSS)

    a questionnaire rating non motor symptoms, ranging from 0 (no symptoms) to 128 (most severe non motor symptoms)

    Measured: 5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  27. RBD Screening Questionnaire

    rates probability for the presence of RBD (REM sleep behavior disorder) using 13 questions; points are given from 0 to 13 with higher points indicating a higher probability for RBD

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  28. Global Physical Activity Questionnaire (GPAQ)

    the GPAQ is a questionnaire provided by the WHO and rates the extent of physical (-in-) activity; rating is done according to the WHO manual available from the WHO website

    Measured: 5-7 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  29. Quality of Life in Essential Tremor Questionnaire (QUEST)

    a questionnaire rating quality of life specifically in ET patients; ranging from 0 (best quality of life) to 120 points (worst quality of life)

    Measured: 5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  30. University of Pennsylvania Smell Identification Test (UPSIT)

    a smell test ranging from 0 (worst olfactory function) to 40 points (best olfactory function)

    Measured: 10-15 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  31. Montreal Cognitive Assessment (MOCA)

    a screening cognitive test rating cognitive dysfunction from 0 (worst) to 30 (best)

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  32. Auditory verbal learning test

    assesses how well patients can remember 15 words after hearing them; the more they can remember, the better

    Measured: 5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  33. Symbol Digit Modalities Test (SDMT)

    patients need to translate specific symbols into numbers (1-9) using a key; they more the can translate in 90 seconds, the better

    Measured: 90 seconds; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  34. Brief Visuospatial Memory Test

    patients can look at 6 figures for 10 seconds each, then they have to reproduce them; 3 trials; the more they remember, the better

    Measured: 2-3 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  35. Comprehensive trail making test 4

    patients have to connect numbers (1 to 21) in ascending order with lines; time is measured in seconds; the faster, the better

    Measured: 1-2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  36. Comprehensive trail making test 5

    patients have to connect numbers (1 to 13) and letters (A to L) in ascending order and alternatingly with lines; time is measured in seconds; the faster, the better

    Measured: 1-2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  37. Regensburg word fluency test

    patients have to list words starting with "g" or "r" alternatingly or things within the categories of "clothes" or "flowers" alternatingly; they have 1 minute for each of the two tasks, the more they can list, the better

    Measured: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  38. EQ-5D

    a quick questionnaire (5 questions) rating quality of life, ranging from 0 (very bad) to 1 (best)

    Measured: 1-2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  39. resilience scale (RS-13)

    a quick questionnaire rating resilience, ranging from 13 (least resilience) to 91 points (highest resilience)

    Measured: 1-2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  40. Pittsburgh Sleep Quality Index (PSQI)

    a quick questionnaire rating sleep quality, ranging from 0 (best sleep) to 21 points (worst sleep quality)

    Measured: 3-4 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  41. Digital Spiral Drawing

    patients are asked to draw Archimedes spirals (a total of 4, 2 with each hand) on a standard tablet PC using a touchpen; the process is done using a free available website-based application (http://www.trsper.com/); the main outcome is visual rating of the spirals ranging from 0 (perfectly normal) to 9 (worst spiral)

    Measured: 2-3 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  42. Schellong Test

    blood pressure test for orthostatic hypotension; blood pressure is measured non-invasively using a automatic device at the left arm in seating position and after 1 and 3 minutes of standing; orthostatic hypotension is defined as a drop in systolic blood pressure of 20mmHg or more and/or of diastolic blood pressure of 10mmHg or more

    Measured: 3.5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  43. serum glial fibrillary acidic protein (sGFAP)

    sGFAP-level is measured from serum using SIMOA-technology

    Measured: 5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  44. serum neurofilament light (sNfL)

    sNfL-level is measured from serum using SIMOA-technology

    Measured: 5 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  45. Transcranial sonography

    the presence of hyperechogenicity (yes/no and area in cm2) of the substantia nigra is measured using transcranial sonography

    Measured: 10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  46. tremor analysis

    tremor frequency and total tremor power are measured

    Measured: 20 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  47. cerebral MRI

    white matter hyperintensities (volume in mm3)

    Measured: 45 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  48. cerebral MRI

    presence of lacunes (number of)

    Measured: 45 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  49. cerebral MRI

    cerebral microbleeds (number of)

    Measured: 45 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  50. cerebral MRI

    volumetry of total brain and regions (in mm3)

    Measured: 45 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  51. cerebral MRI

    Diffusion tensor imaging parameters (fractional anisotropy, mean diffusivity, radial diffusivity)

    Measured: 45 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  52. cerebral MRI

    nigrosome-1-imaging (presence of swallow tail sign yes vs. no)

    Measured: 45 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  53. optic coherence tomography (OCT)

    thickness of retinal nerve fiber layer in both eyes and each quadrant and in vicinity of the macula and papilla

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  54. optic coherence tomography (OCT)

    thickness of ganglion cell layer in both eyes and each quadrant and in vicinity of the macula and papilla

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  55. optic coherence tomography (OCT)

    thickness of inner plexiform layer in both eyes and each quadrant and in vicinity of the macula and papilla

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  56. optic coherence tomography (OCT)

    thickness of choroidea in both eyes and each quadrant and in vicinity of the macula and papilla

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

  57. Olfactory mucosa swab

    swab of the olfactory mucosa testing for alpha-synuclein using a seeding assay (outcome: presence of misfolded alpha-synuclein yes vs. no)

    Measured: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start4 Apr 2024
  3. Primary completion28 Feb 2026
  4. Study completion30 Apr 2034 (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
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06349538
Sponsor's protocol ID
35-435 ex 22/23
Status last verified
Oct 2026
First submitted
28 Mar 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.

    PubMed 29193359

  • Doustar J, Torbati T, Black KL, Koronyo Y, Koronyo-Hamaoui M. Optical Coherence Tomography in Alzheimer's Disease and Other Neurodegenerative Diseases. Front Neurol. 2017 Dec 19;8:701. doi: 10.3389/fneur.2017.00701. eCollection 2017.

    PubMed 29312125

  • Stefani A, Iranzo A, Holzknecht E, Perra D, Bongianni M, Gaig C, Heim B, Serradell M, Sacchetto L, Garrido A, Capaldi S, Sanchez-Gomez A, Cecchini MP, Mariotto S, Ferrari S, Fiorini M, Schmutzhard J, Cocchiara P, Vilaseca I, Brozzetti L, Monaco S, Jose Marti M, Seppi K, Tolosa E, Santamaria J, Hogl B, Poewe W, Zanusso G; SINBAR (Sleep Innsbruck Barcelona) group. Alpha-synuclein seeds in olfactory mucosa of patients with isolated REM sleep behaviour disorder. Brain. 2021 May 7;144(4):1118-1126. doi: 10.1093/brain/awab005.

    PubMed 33855335

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Tremor, run by Medical University of Graz at 1 site in Austria.

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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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 Austria. 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?

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?

Prevalence of ET-plus (time frame: approx. 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06349538, which also lists 3 linked publications.

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 29 Oct 2026.

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