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Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
Can cardiovascular risk management be improved by shared care with general practice to prevent cognitive decline
William J Davison1, Phyo K Myint2, Yoon K Loke3
1Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK.
Insights
Recruiting patients with cognitive impairment after stroke or TIA for vascular risk management trials is feasible, but participant retention is challenging. Poor risk factor control indicates the intervention needs refinement for future studies.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Public Health
Background:
- Cognitive impairment and dementia post-cerebrovascular disease are rising concerns in the UK.
- Multimodal vascular risk factor management is a potential preventative strategy for post-stroke cognitive decline, but its effectiveness is unproven, especially in vulnerable patients.
- The study assessed the feasibility of recruiting and retaining patients with early cognitive impairment following stroke or transient ischaemic attack (TIA) for a trial focused on enhanced vascular risk factor management.
Purpose of the Study:
- To evaluate the feasibility of participant recruitment and retention in a trial for enhanced vascular risk factor management in patients with mild cognitive impairment (MCI) post-stroke or TIA.
- To assess the impact of a multimodal intervention on vascular risk factors (blood pressure, cholesterol, HbA1C, heart rate, anticoagulation).
- To observe cognitive changes in patients with MCI and normal cognition over 12 months.
Main Methods:
- A single-center, open-label trial randomized adults with recent stroke/TIA and MCI to a three-monthly multimodal vascular risk factor intervention or usual care.
- Intervention focused on blood pressure, cholesterol, HbA1C (for diabetes), heart rate, and anticoagulation (for atrial fibrillation).
- An embedded observational cohort included similar patients with normal cognition, all receiving usual care; cognitive screening was repeated after 12 months.
Main Results:
- Recruitment was feasible, with 73 participants in the randomized trial and 94 in the observational cohort (21.8% of screened).
- Participant retention was poor, with 47.9% dropout in the randomized trial.
- Baseline risk factor control was generally poor and did not significantly improve; the observational cohort showed greater cognitive decline, with no difference between randomized groups.
Conclusions:
- Recruitment to this type of study is feasible, but participant retention poses a significant challenge.
- Poor risk factor control suggests the intervention's application was insufficient, necessitating protocol changes for future trials, potentially reducing reliance on primary care.
- Future trials should consider including participants with normal cognition post-stroke, as they may be at higher risk for cognitive decline.
Background:
Cognitive impairment and dementia following cerebrovascular disease are increasingly common in the UK. One potential strategy to prevent post-stroke cognitive decline is multimodal vascular risk factor management. However, its efficacy remains uncertain and its application in vulnerable patients with incident cerebrovascular disease and early cognitive impairment has not been assessed. The primary aim of this study was to assess the feasibility of recruitment and retention of patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA) to a trial of enhanced vascular risk factor management combining primary and secondary care.
Methods:
In this single centre, open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI) were randomised 1:1 to a three-monthly multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP). Chosen risk factors were blood pressure (BP), total cholesterol, blood glucose (HbA1C) in those with diabetes, and heart rate and adequacy of anticoagulation in those with atrial fibrillation (AF). Similar patients with normal cognition were enrolled in an embedded observational cohort and also received usual care from the GP. Repeat cognitive screening was undertaken in all participants after 12 months.
Results:
Seventy three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened). From the randomised trial 35/73 (47.9%) dropped out before final follow-up. In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up. The observational cohort demonstrated greater decline in cognitive test scores at 12 months, with no difference between the randomised groups.
Conclusions:
Recruitment to such a study was feasible, but retention of participants was difficult and generally poor rates of risk factor control suggested insufficient application of the intervention. Consequently, successful scaling up of the trial would require protocol changes with less reliance on primary care services. Any future trial should include participants with normal cognition post-stroke as they may be at greatest risk of cognitive decline.
Trial Registration:
ISRCTN, ISRCTN42688361 . Registered 16 April 2015.
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