|- candidate number||14627|
|- NTR Number||NTR3928|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-mrt-2013|
|- Secondary IDs||2012/393 METC Regio Arnhem/Nijmegen|
|- Public Title||Evaluation of balance disorders or vestibular disorders in Parkinson's disease and atypical Parkinson's disease variants.|
|- Scientific Title||Neurovestibular research in Parkinson's disease and atypical Parkinsonisms.|
|- ACRONYM||NeuroVest Trial|
|- hypothesis||1. 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) studied||Parkinson's disease, Atypical Parkinsonism|
|- Inclusion criteria||1. Age > 18 years;|
2. Parkinson's disease, atypical variants (MSA, PSP, CBS and vascular) or healthy control.
|- Exclusion criteria||1. No cognitive problems;|
2. Doesn't use hypnotica, sedativa or anxiolytica;
3. No other known neuro-oto-ophthalmological problems.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-jan-2016|
|- Target number of participants||150|
|- Interventions||1. BAEP;|
(Total duration: 2,5 hours, only 1 visit)
|- Primary outcome||Comparison of the test results correlate with risk of falling, vestibular complaints or disease progression.|
|- Secondary outcome||1. Correlation of the test results with future fall risk;|
2. Prevalence of vestibular disorders in Parkinson's disease or atypical variants.
|- Timepoints||1. First year: 50 inclusions;|
2. Second: 100 inclusions;
3. Third: 150 inclusions.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Venhovens|
|- CONTACT for SCIENTIFIC QUERIES||Drs. J. Venhovens|
|- Sponsor/Initiator ||Canisius Wilhelmina Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||The 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)|
|- RECORD||29-mrt-2013 - 3-mei-2013|