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  • Effects of brain training on brain blood flow (The Cognition and Flow Study—CogFlowS): protocol for a feasibility randomised controlled trial of cognitive training in dementia

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Mental health
Protocol
Effects of brain training on brain blood flow (The Cognition and Flow Study—CogFlowS): protocol for a feasibility randomised controlled trial of cognitive training in dementia
  1. Lucy Beishon1,
  2. Rachel Evley2,
  3. Ronney B Panerai1,3,
  4. Hari Subramaniam4,
  5. Elizabeta Mukaetova-Ladinska5,
  6. Thompson Robinson1,3,
  7. Victoria Haunton1,3
  1. 1 Cardiovascular Sciences, University of Leicester College of Medicine Biological Sciences and Psychology, Leicester, UK
  2. 2 Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
  3. 3 NIHR Leicester Biomedical Research Centre, British Heart Foundation Cardiovascular Research Centre, University of Leicester, Leicester, UK
  4. 4 The Evington Centre, Leicestershire Partnership NHSTrust, Leicester, UK
  5. 5 Department of Neuroscience, Psychology and Behaviour, University of Leicester, Leicester, UK
  1. Correspondence to Dr Lucy Beishon; lb330{at}le.ac.uk

Abstract

Introduction Cognitive training is an emerging non-pharmacological treatment to improve cognitive and physical function in mild cognitive impairment (MCI) and early Alzheimer’s disease (AD). Abnormal brain blood flow is a key process in the development of cognitive decline. However, no studies have explored the effects of cognitive training on brain blood flow in dementia. The primary aim of this study is to assess the feasibility for a large-scale, randomised controlled trial of cognitive training in healthy older adults (HC), MCI and early AD.

Methods and analysis This study will recruit 60 participants, in three subgroups of 20 (MCI, HC, AD), from primary, secondary and community services. Participants will be randomised to a 12-week computerised cognitive training programme (five × 30 min sessions per week), or waiting-list control. Participants will undergo baseline and follow-up assessments of: mood, cognition, quality of life and activities of daily living. Cerebral blood flow will be measured at rest and during task activation (pretraining and post-training) by bilateral transcranial Doppler ultrasonography, alongside heart rate (3-lead ECG), end-tidal CO2 (capnography) and beat-to-beat blood pressure (Finometer). Participants will be offered to join a focus group or semistructured interview to explore barriers and facilitators to cognitive training in patients with dementia. Qualitative data will be analysed using framework analysis, and data will be integrated using mixed methods matrices.

Ethics and dissemination Bradford Leeds Research Ethics committee awarded a favourable opinion (18/YH/0396). Results of the study will be published in peer-reviewed journals, and presented at national and international conferences on ageing and dementia.

Trials registration number NCT03656107; Pre-results.

  • cognitive impairment
  • neuroimaging
  • cerebral haemodynamics
  • alzheimer’s disease
  • mild cognitive impairment
  • transcranial doppler ultrasonography

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2018-027817

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    Footnotes

    • Contributors The quantitative arm of the study was conceived and designed by LB, VH, RBP and TR. LB and RE designed the qualitative arm of the study. HS and EM-L reviewed and edited the protocol. All authors assisted in drafting this manuscript.

    • Funding This study was reviewed and funded by the Dunhill Medical Trust, and LB is a Dunhill research training fellow (RTF1806\27). TR is an NIHR Senior Investigator. This funding source had and will not have a role in the design, conduct, analyses, interpretation of the data or decision to submit results. The cognitive training programme is being provided by Lumosity free of charge, as part of an industry-institution collaboration through the Human Cognition Project. Lumosity is providing advice and support on the composition and nature of the programme. However, this study is financially independent of Lumosity, and Lumosity cannot influence or change the results or outcomes of this study.

    • Competing interests None declared.

    • Ethics approval Ethical approval was obtained from the Bradford Leeds Research Ethics Committee (18/YH/0396).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.