Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project

NCT05649800 | Recruiting

• 1 other identifier: 0872
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

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

Conditions

Cognitive Dysfunction; Stroke; Dementia; Depression; Delirium

Outcome Measures

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.

  3 years

Study Arms (5)

Healthy

Healthy adults ages over 65 years

Stroke

Stroke patients aged over 65 years

Dementia

Dementia patients aged over 65 years

Depression

Depression patients aged over 65 years

Delirium

Delirium patients aged over 65 years

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and Stroke, Dementia, Depression and Delirium Individuals aged over 65 years

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (2)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Leicestershire Partnership Trust

Leicester, Leicestershire, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke; Dementia; Depression; Delirium

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Jatinder Minhas

  Clinical Associate Professor of Stroke Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Ball

CONTACT

07551300119; jdb58@le.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 14, 2022
• Study Start: March 17, 2023
• Primary Completion: November 26, 2025
• Study Completion (Estimated): August 26, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)