Exploring brain blood flow and function in stroke, depression, dementia, and delirium
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
This study is trying to see how different imaging techniques can help us understand blood flow in the brain of people with stroke, depression, dementia, and delirium, as well as healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 2 sites (Leicester, Leicestershire and 1 other locations) |
| Trial ID | NCT05649800 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using advanced imaging techniques, such as Transcranial Doppler Ultrasonography and Near Infrared Spectroscopy, to evaluate changes in brain blood flow and neurovascular function in various populations, including healthy individuals and those with cognitive dysfunction, stroke, depression, and delirium. Participants will undergo assessments in a controlled environment, with specific adaptations for those with delirium to minimize environmental changes. The study will also explore optimal stimuli for neurovascular coupling and gather data to inform future research designs.
Who should consider this trial
Good fit: Ideal candidates include healthy adults over 65 and individuals diagnosed with dementia, depression, or delirium.
Not a fit: Patients with poorly controlled medical conditions affecting cognitive function or those who are clinically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of brain function in patients with cognitive disorders, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: While similar studies have explored neurovascular coupling, this specific approach using integrated imaging techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Leicester, Leicestershire and 1 other locations
- University Hospitals of Leicester NHS Trust — Leicester, Leicestershire, United Kingdom (Recruiting)
- Leicestershire Partnership Trust — Leicester, Leicestershire, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Dr Jatinder Minhas — Clinical Associate Professor of Stroke Medicine
- Study coordinator: James Ball
- Email: jdb58@le.ac.uk
- Phone: 07551300119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.