NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University of California, San Diego
Conditions: Parkinson Disease, Orthostatic Hypertension, Cognitive Change, Cognitive Impairment, Cognitive Decline
Interventions: Head-up tilt table
The goal of clinical trial is to learn about how blood pressure fluctuations affect cognitive performance (thinking abilities) and brain blood flow in persons with Parkinson's disease with and without orthostatic hypotension (low blood pressure when standing). The main questions it aims to answer are: * Is there a certain level of blood pressure that correlates with change in cognitive performance while upright? * Is there a certain level of change in brain blood flow that correlates with change in cognitive performance when upright? * How does cognitive performance differ between persons with Parkinson's disease that have orthostatic hypotension and those without orthostatic hypotension? * How does cognitive performance differ between the supine (laying down) and upright positions? * How do blood pressure and brain blood predict changes in cognitive performance over two years? Participants in this study will undergo the following procedures: * Complete a screening visit with questionnaires, medical history, physical exam, and head-up tilt-table test. * Attend one baseline study visit, during which they will undergo a battery of computerized cognitive tests repeated twice: once while laying down and once while upright on a tilt table. Simultaneously, during the experiments we will measure blood pressure using a wrist-worn device and inflatable arm cuff and will measure brain blood flow using functional near-infrared spectroscopy (fNIRS), a non-invasive device that uses light sensors to detect changes in brain blood flow. * Attend one two-year follow-up visit, during which they will repeat a battery of computerized cognitive tests repeated twice: once while laying down and once while upright on a tilt table. During this visit, like before, we will measure blood pressure using a wrist-worn device and inflatable arm cuff and will measure brain blood flow using functional near-infrared spectroscopy (fNIRS). Researchers will compare participants with Parkinson's disease with and without orthostatic hypotension in the laying down and upright positions to see if there are changes in thinking abilities between these groups.
Sex: ALL
Age: 50 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Clinical diagnosis of idiopathic Parkinson's disease (PD) using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria (Postuma, 2015) * Age least 50 years old * Hoehn \& Yahr (H\&Y) stages I to III (early to moderate stage PD) * Proficiency in the English language (native English speaker level) Exclusion Criteria: * Any involuntary movements (i.e., tremor or dyskinesia) greater than 3 cm in amplitude, since the motion artifact can interfere with BP monitor cuff * Taking antihypertensive medications or alpha-adrenergic blocking medications since these can cause hypotension. * Dementia (including PD dementia (Emre, 2007) characterized by either Dementia Rating Scale 2 (DRS-2) score) 124 or less or clinical evidence of impaired instrumental activities of daily living * History of deep brain stimulation (DBS) surgery * Any unstable, active medical problem, e.g., decompensated heart failure, liver failure, etc. * Moderate or severe carotid artery stenosis (according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (Ferguson, 1999) * History of cerebral infarction or hemorrhage * Uncontrolled diabetes or any other systemic disease that causes autonomic failure * Any terminal illness with life expectancy less than 2 years * Illiteracy * Impairment of hearing or vision that is not corrected by devices (e.g., hearing aids or glasses) * Currently pregnant (will be confirmed with a urine pregnancy screening test in people of child-bearing potential) * Any other condition, which, in the opinion of the investigator, could place the participant at increased risk (e.g., substance abuse)