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

Evaluating the Feasibility of Remote Haemodynamic Monitoring in a Cohort of Multi-ethnic Chronic Stroke Patients Using a Novel User Interface and Artificial Intelligence Algorithms

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

Study Overview

• Status: Recruiting
• Conditions: Depression; Stroke; Delirium; Cognitive Dysfunction; Dementia

Detailed Description

Healthy participants and those with dementia or depression will be invited to one assessment in the Cerebral Haemodynamics in Ageing and Stroke Medicine (CHiASM) research laboratory based at the Leicester Royal Infirmary. For participants with delirium, this assessment will be carried out on the ward to minimise changes to their environment. For participants with stroke, an assessment will be made by LB or JM as to whether it is most appropriate to undertake the study assessment in the lab or on the ward. Capacity will be assessed in compliance with the provisions of the Mental Capacity Act (England and Wales) 2005 to ensure full consent can be given by the potential research participant.

Participants will under-go two recordings of continuous beat-to-beat cerebral blood flow velocity (CBV) using transcranial Doppler ultrasonography (TCD), blood pressure (BP) using a Finometer, end-tidal CO2 (EtCO2) using nasal capnography, heart rate (HR) using a 3-lead ECG, and cortical oxygenation via pre-frontal near-infrared spectroscopy (NIRS). The first recording will last 5 minutes and will be conducted at rest. The second recording will last approximately 15 minutes and use four stimulation paradigms (cognitive, motor, sensory, and visual).

At the end of the cerebrovascular assessment, participants will be asked to complete questionnaires formally assessing cognitive function (Montreal Cognitive Examination - MoCA), mood (Geriatric Depression-Scale 15 - GDS-15), and delirium (4AT), where these weren't conducted as part of the screening process. Stroke patients will undergo additional scales to assess stroke severity (National Institute of Health Stroke Scale [NIHSS]) and dependency (modified Rankin Scale [mRS]).

Balance and community monitoring sub-study Suitable participants will be invited to undergo an additional or separate assessment on integrated TCD-NIRS during a balance assessment that assesses postural sway in different conditions. These include with visual input or standing on foam with and without the eyes open Participants in the balance sub-study will undergo additional measurements of lying and standing BP, and a fall assessment (Falls Efficacy Scale International [FES-I]). All participants will be offered an optional follow-up using Infiniwell remote monitoring systems (Lifesignals© Biosensor https://lifesignals.com/wearable-biosensors/1ax-biosensor/) in the community.

Follow-up assessment Participants with a diagnosis of stroke or delirium will be asked to return at 3 months for a follow-up neurovascular assessment (identical to the first). Only the stroke and delirium groups are being asked to return at follow-up as these two conditions are likely to improve over time.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: James Ball; Phone Number: 07551300119; Email: jdb58@le.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Recruiting
      • University Hospitals of Leicester NHS Trust
      • Contact: Lucy Beishon, MBChB; Phone Number: 01162523134; Email: lb330@le.ac.uk
      • Principal Investigator: Lucy Beishon, MBChB
    • Leicester, Leicestershire, United Kingdom
      • Not yet recruiting
      • Leicestershire Partnership Trust
      • Contact: Lucy Beishon, MBChB; Phone Number: 01162523134; Email: lb330@le.ac.uk
      • Contact: Lucy Beishon; Phone Number: 01162523134; Email: lb330@le.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Leicester
• Investigators: Principal Investigator: Dr Jatinder Minhas, Clinical Associate Professor of Stroke Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): November 26, 2025
• Study Completion (Estimated): August 26, 2026

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Stroke; Delirium; Cognitive Dysfunction; Depression; Dementia
• Other Study ID Numbers: 0872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No