Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Leicester
About this trial
The goal of this observational study is to determine the feasibility of using integrated Transcranial Doppler Ultrasonography or Near Infrared Spectroscopy to detect changes in cerebral autoregulation and neurovascular coupling in healthy, stroke, dementia, depression and delirium populations. We also aim to:
* Determine the optimal stimulus for neurovascular coupling * To derive sample size estimates for a future study * To develop a multilevel, multivariate model that can be applied to future datasets
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults aged over 65 years, free from medical comorbidities or medications that can adversely affect cognitive function or cerebral haemodynamics;
Stable, well controlled comorbidities (e.g. hypertension);
A diagnosis of dementia (major neurocognitive disorder), depression, or delirium, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria;
Participants on or off anti-dementia drug therapy (acetylcholinesterase inhibitors, NMDA receptor antagonists), and antidepressants;
Disqualifiers
Poorly controlled medical comorbidities affecting cerebral haemodynamics or cognitive function (e.g., heart failure, hypertension, type two diabetes);
Clinically unstable or too unwell to cooperate with the study protocol;
Lacks capacity or personal consultee to consent to the study.
Trial population
Healthy and Stroke, Dementia, Depression and Delirium Individuals aged over 65 years
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
140 Participants
are grouped into 5 trial groupsGroup A: Healthy
Group B: Stroke
Group C: Dementia
Group D: Depression
Group E: Delirium
Trial outcomes
Primary outcomes
1
Good quality TCD-NIRS data
Number and percentage of complete TCD-NIRS assessments with good quality data (above the upper 95% confidence limit for the mean square error of the sample for at least one parameter) across all consented participants.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov