Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution
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|ClinicalTrials.gov Identifier: NCT01518751|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : September 30, 2015
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.
|Condition or disease|
|Parkinson`s Disease - Autonomic Dysregulation|
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Observational Model:||Case Control|
|Official Title:||Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution A Monocentric Study to Investigate the Development of Symptoms of Autonomic Dysregulation in Parkinson`s Disease|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
- orthostatic hypotension [ Time Frame: during study visit ]drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test
- delayed gastric emptying [ Time Frame: during study visit ]statistical difference in mean gastric emptying assessed via octanoate breath test
- long term blood pressure [ Time Frame: during 7d after study visit at home ]mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings
- heart rate variability [ Time Frame: during study visit ]difference in heart rate variability or spectral analysis of heart rate variability?
- arterial stiffening [ Time Frame: during study visit ]difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?
- oesophageal motility [ Time Frame: during study visit ]high-density manometry to measure aspects of oesophageal motility
- subjective symptoms of gastrointestinal and cardiovascular dysfunction [ Time Frame: during study visit ]validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }
- Clinical assessment [ Time Frame: during study visit ]UPDRS part III and MoCA score (Nasreddine, 2005, p14186)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518751
|University Hospital Zurich, Neurology|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Christian Baumann, Ass. Prof., MD||University Hospital Zurich, Neurology|