NCT05649800 Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project
| NCT ID | NCT05649800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Cognitive Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2025-11-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2023-03-17 with a primary completion date of 2025-11-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
* 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.
Contact & Investigator
Dr Jatinder Minhas
PRINCIPAL INVESTIGATOR
Clinical Associate Professor of Stroke Medicine
Frequently Asked Questions
Who can join the NCT05649800 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649800 currently recruiting?
Yes, NCT05649800 is actively recruiting participants. Contact the research team at jdb58@le.ac.uk for enrollment information.
Where is the NCT05649800 trial being conducted?
This trial is being conducted at Leicester, United Kingdom, Leicester, United Kingdom.
Who is sponsoring the NCT05649800 clinical trial?
NCT05649800 is sponsored by University of Leicester. The principal investigator is Dr Jatinder Minhas at Clinical Associate Professor of Stroke Medicine. The trial plans to enroll 140 participants.