Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project
Recruiting · NCT05649800 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Leicester
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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;
- A diagnosis of ischaemic (IS) or haemorrhagic (ICH) stroke according to clinical and/or radiological findings, within 72 hours of symptom onset
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- University Hospitals of Leicester NHS Trust - Leicester, Leicestershire, United Kingdom
- Leicestershire Partnership Trust - Leicester, Leicestershire, United Kingdom