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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
140 Participants
are grouped into 5 trial groupsSponsors and collaborators
Source ClinicalTrials.gov