An observational study in Parkinson's Disease - Autonomic Dysregulation, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-30.
Sponsored by University of Zurich · Observational
Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common amongst parkinson patients. The overall aim of this study is to examine blood pressure regulation and esophageal motility and gastric emptying in Parkinson's disease (PD) patients.
The investigators hypothesize that - compared to age-matched controls - PD patients display an altered regulation of blood pressure, altered gastroesophageal motility, and delayed gastric emptying. These symptoms occur already early in the disease process, but aggravate with progression of the disease.
The investigators will perform a 7-day blood pressure measurement, measurement of central blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to assess orthostatic function, high resolution manometry assessments during swallowing acts, and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each Hoehn\&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be interpreted in relation to the severity of PD motor symptoms.
The investigators anticipate that blood pressure dysregulation and gastroesophageal motility disturbances will be present only in PD subjects, but not in matched controls without neurological disorders and without any extrapyramidal motor signs. Furthermore, the investigators expect to find an association between motor impairment and the severity of these autonomic symptoms, however, that according to the Braak staging, subtle disturbances must already be present in the early stages of PD.
University of Zurich is the lead sponsor of 1,048 studies on the registry; 132 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects included in this trial must fulfil the he following criteria:
male / female subjects, aged 50-70 years
18 PD patients
9 subjects Hoehn \& Yahr stage 2; disease duration 4-8 years
12 healthy control subjects
Inclusion criteria: - informed, written \& formal consent for participation
Exclusion criteria: - Antihypertensive treatment
orthostatic hypotension
drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test
Time frame: during study visit
delayed gastric emptying
statistical difference in mean gastric emptying assessed via octanoate breath test
Time frame: during study visit
long term blood pressure
mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings
Time frame: during 7d after study visit at home
heart rate variability
difference in heart rate variability or spectral analysis of heart rate variability?
Time frame: during study visit
arterial stiffening
difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?
Time frame: during study visit
oesophageal motility
high-density manometry to measure aspects of oesophageal motility
Time frame: during study visit
subjective symptoms of gastrointestinal and cardiovascular dysfunction
validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }
Time frame: during study visit
Clinical assessment
UPDRS part III and MoCA score (Nasreddine, 2005, p14186)
Time frame: during study visit
The record gives a start of Dec 2011, a primary completion of Dec 2013 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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