Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab..
- Who it may be relevant to
- Registry conditions: Essential Tremor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor - a Prospective Cohort Study
Overview
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.
Interventions
- Diagnostic test Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.
see previous descriptions
Primary outcome measures
- Prevalence of ET-plus [Time frame: approx. 2 years]
Secondary outcome measures (12)
- Age of ET patients [Time frame: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- Sex of ET patients [Time frame: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- Family history [Time frame: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- Symptom leading to ET-plus classification [Time frame: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- current and former medication for essential tremor [Time frame: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- subjective disease course of ET [Time frame: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- responsivity to alcohol [Time frame: 1 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- presence of cardiovascular risk factors [Time frame: 2 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) parts I-IV [Time frame: 20-30 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- modified Essential Tremor Rating Assessment Scale (mTETRAS) [Time frame: 10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- Scale for the assessment and rating of ataxia (SARA) [Time frame: 5-10 minutes; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
- Verbal fluency animals (part of the CERAD-plus test battery) [Time frame: 1 minute; Baseline (recruiting time approx. 2 years) and follow-up (5 years after individual baseline)]
Eligibility criteria
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 informed consent.
- age above 18 years.
Exclusion criteria
- Patient is not able or not willing to give informed consent.
- Existence of a legal representative.
- age below 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Medical University of Graz — Graz
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 No PMID 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. PMID 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 PMID 33855335
Identifiers
NCT: NCT06349538 · 35-435 ex 22/23