ClinicalTrials.gg
Active, not recruitingNCT06349538Updated Oct 29, 2026

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

An observational study in Essential Tremor, sponsored by Medical University of Graz. Active, not recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Medical University of Graz · Observational

Updated Oct 29, 2026Now Active, not recruitingPrimary completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.
  • 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)

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.

02

Conditions studied

  • Essential Tremor

Keywords

  • essential tremor
  • subtypes
  • neurodegeneration
  • biomarkers
  • MRI
  • imaging
  • sGFAP
  • sNfL
  • tremor analysis
03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 100 is above the median of 89 across 70 observational studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .
  • age above 18 years.

Exclusion criteria

Exclusion Criteria:

  • Patient is not able or not willing to give .
  • Existence of a legal representative.
  • age below 18 years
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Essential tremor patients

    Essential 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

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

Interventions

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

    see previous descriptions

06

What researchers measure

Primary outcomes

  1. Prevalence of ET-plus

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

    Time frame: approx. 2 years

Secondary outcomes

  1. Age of ET patients

    age at disease onset and age at baseline

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

  2. Sex of ET patients

    male, female, other

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

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

  48. cerebral MRI

    presence of lacunes (number of)

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

  49. cerebral MRI

    cerebral microbleeds (number of)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

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

07

Study locations

1 site
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Feb 2026, 22 months.

Of 26 observational studies under Essential Tremor, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25. This study's 22 months is below that.

Primary completion moved once since we started tracking on Sep 25, 2026: Apr 2026 → Feb 2026, on Oct 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2024
First posted
Apr 5, 2024
StartActual
Apr 4, 2024
Primary completionActual
Feb 28, 2026was Apr 2026
CompletionEst.
Apr 30, 2034
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Active, not recruiting
changed Oct 29, 2026
Primary completion
Apr 30, 2026→Feb 28, 2026 (actual)
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Enrolling by invitation→Active, not recruiting
    Primary completion Apr 30, 2026→Feb 28, 2026 (now actual)
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06349538
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Apr 4, 2024
Primary completion
Feb 28, 2026
Completion
Apr 30, 2034 (estimated)
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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