Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
NCT ID: NCT06349538
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2024-04-04
2034-04-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.
see previous descriptions
Interventions
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Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab.
see previous descriptions
Eligibility Criteria
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Inclusion Criteria
* Patient is able and willing to give informed consent.
* age above 18 years.
Exclusion Criteria
* Existence of a legal representative.
* age below 18 years
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University of Graz
Graz, Austria, Austria
Countries
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References
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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.
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.
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.
Other Identifiers
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35-435 ex 22/23
Identifier Type: -
Identifier Source: org_study_id
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