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

Sponsor: University of Leicester

NCT ID: NCT05649800

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 41 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
65 Years and over
Who
All
Number of participants
140
Started
2023-03-17
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for cognitive dysfunction
  • • Clinical study - 140 participants
  • • 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

Who can take part?

  • • Ages 65 Years and over
  • • Diagnosed with cognitive dysfunction

Where?

  • • Leicester - University Hospitals of Leicester NHS Trust
  • • Leicester - Leicestershire Partnership Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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

More detail

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.

Cognitive DysfunctionStrokeDementiaDepressionDelirium

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 65 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Healthy adults aged over 65 years, free from medical other health conditions or medications that can adversely affect...
  • ✓Stable, well controlled other health conditions (e.g. hypertension);
  • ✓A diagnosis of dementia (major neurocognitive disorder), depression, or delirium, according to the Diagnostic and...
  • ✓Participants on or off anti-dementia drug therapy (acetylcholinesterase inhibitors, NMDA receptor antagonists), and...
  • ✓A diagnosis of ischaemic (IS) or haemorrhagic (ICH) stroke according to clinical and/or radiological findings,...

Who cannot take part

  • ✗Poorly controlled medical other health conditions affecting cerebral haemodynamics or cognitive function (e.g., heart failure,...
  • ✗Clinically unstable or too unwell to cooperate with the study protocol;
  • ✗Lacks capacity or personal consultee to consent to the study.
See the full 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.

Where Is This Study? (2 UK sites)

University Hospitals of Leicester NHS Trust

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Lucy Beishon, MBChBPrincipal Investigator
Lucy Beishon, MBChB01162523134lb330@le.ac.uk

Leicestershire Partnership Trust

Leicester, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Lucy Beishon, MBChB01162523134lb330@le.ac.uk

How to Get in Touch

James Ball

Sponsor contact

CONTACT

07551300119 jdb58@le.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-11