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Evaluation of balance disorders or vestibular disorders in Parkinson's disease and atypical Parkinson's disease variants.


- candidate number14627
- NTR NumberNTR3928
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mrt-2013
- Secondary IDs2012/393 METC Regio Arnhem/Nijmegen
- Public TitleEvaluation of balance disorders or vestibular disorders in Parkinson's disease and atypical Parkinson's disease variants.
- Scientific TitleNeurovestibular research in Parkinson's disease and atypical Parkinsonisms.
- ACRONYMNeuroVest Trial
- hypothesis1. Different neuropathological mechanisms in Parkinson's disease and atypical Parkinsonism concerning the risk of falling;
2. Research concerning the diagnostic accuracy and sensitivity of VEMP and SVV.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Atypical Parkinsonism
- Inclusion criteria1. Age > 18 years;
2. Parkinson's disease, atypical variants (MSA, PSP, CBS and vascular) or healthy control.
- Exclusion criteria1. No cognitive problems;
2. Doesn't use hypnotica, sedativa or anxiolytica;
3. No other known neuro-oto-ophthalmological problems.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2013
- planned closingdate1-jan-2016
- Target number of participants150
- Interventions1. BAEP;
2. ENG;
3. VEMP;
4. SVV;
5. Questionnaire.
(Total duration: 2,5 hours, only 1 visit)
- Primary outcomeComparison of the test results correlate with risk of falling, vestibular complaints or disease progression.
- Secondary outcome1. Correlation of the test results with future fall risk;
2. Prevalence of vestibular disorders in Parkinson's disease or atypical variants.
- Timepoints1. First year: 50 inclusions;
2. Second: 100 inclusions;
3. Third: 150 inclusions.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. J. Venhovens
- CONTACT for SCIENTIFIC QUERIESDrs. J. Venhovens
- Sponsor/Initiator Canisius Wilhelmina hospital
- Funding
(Source(s) of Monetary or Material Support)
Canisius-Wilhelmina hospital
- PublicationsN/A
- Brief summaryThe neurovestibular system of patients with Parkinsonís disease and atypical Parkinsonisms (like PSP, MSA, vascular parkinsonism and cortico-basal syndrome) are studied clinically (clinical examination and questionnaires) and by neurophysiologic testing (VEMP, BAEP, ENG and SVV). Patients and healthy volunteers are invited to participate in this study. The primary aim of this study is to have a better understanding of the neurovestibular pathofysiological mechanisms contributing to falling in parkinsonís disease and atypical parkinsonisms and to evaluate vestibular complaints in these patients.
- Main changes (audit trail)
- RECORD29-mrt-2013 - 3-mei-2013


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