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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (2 UK sites)
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Leicestershire Partnership Trust
Leicester, United Kingdom
How to Get in Touch
James Ball
Sponsor contactCONTACT
