Cognitive DysfunctionVESPARNCT05649800
Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project
An observational study of Cognitive Dysfunction and Stroke, run by University of Leicester at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Stroke, Dementia
- How many people
- 140 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 17 Mar 2023to 26 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy and Stroke, Dementia, Depression and Delirium Individuals aged over 65 years
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
Lucy Beishon, MBChB, 01162523134, lb330@le.ac.uk
Lucy Beishon, MBChB
- Not yet recruiting
Leicestershire Partnership Trust
Leicester, Leicestershire
Lucy Beishon, 01162523134, lb330@le.ac.uk
Lucy Beishon, MBChB, 01162523134, lb330@le.ac.uk
About this study
Official title: 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
Read the 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.
- Conditions
- Cognitive Dysfunction, Stroke, Dementia, Depression, Delirium
- Medical subject headings
- Cognitive Dysfunction, Stroke, Dementia, Depression, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start17 Mar 2023
- Primary completion26 Nov 2025
- Study completion26 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Jatinder Minhas, Principal investigator, Clinical Associate Professor of Stroke Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649800
- Sponsor's protocol ID
- 0872
- Acronym
- VESPAR
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2022
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ball JD, Panerai RB, Minhas JS, Edwards O, Alshehri A, Sensier Y, Robinson T, Beishon LC. Simultaneous macrovasculature and microvasculature cerebral autoregulation derived from the transfer function analysis of integrated cerebral haemodynamic data in older adults. Physiol Meas. 2026 May 6;47(5). doi: 10.1088/1361-6579/ae63a3.
PubMed 42019546
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05649800
- Acronym / sponsor ID
- VESPAR / 0872
- Conditions
- Cognitive Dysfunction, Stroke, Dementia, Depression, Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Aug 2026 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy and Stroke, Dementia, Depression and Delirium Individuals aged over 65 years
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Good quality TCD-NIRS data
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Derived from this study: PubMed 42019546Ball JD, Panerai RB, Minhas JS, Edwards O, Alshehri A, Sensier Y, Robinson T, Beishon LC. Simultaneous macrovasculature and microvasculature cerebral autoregulation derived from the transfer function analysis of integrated cerebral haemodynamic data in older adults. Physiol Meas. 2026 May 6;47(5). doi: 10.1088/1361-6579/ae63a3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Jatinder Minhas principal investigator
Clinical Associate Professor of Stroke Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Stroke, run by University of Leicester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Ball (07551300119, jdb58@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good quality TCD-NIRS data (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.