The Effects of Brain Training on Brain Blood Flow: The Cognition and Flow Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Percentage of Participants Able to Successfully Complete the Minimum (15 Mins, 3x Per Week, for 8 Weeks) and Maximum (30 Mins, 5x Per Week, for 12 Weeks) Criteria CT Program and Complete All Assessments
研究概览
简要总结
About the research
There are currently 850,000 people living with dementia in the United Kingdom. It is now understand that Alzheimer's disease (AzD) can result from damaged blood vessels in the brain. Brain blood flow can be measured using ultrasound, known as transcranial Doppler ultrasonography (or TCD).
Brain training (BT) uses exercises or brain-teasers to try to make the brain work faster and more accurately. In recent years, BT has been used to try to improve memory, mood, learning, quality of life, and ability to carry out every-day activities in people with dementia.
Aims
- To find out how acceptable and manageable this BT program is for people with dementia to undertake larger studies of BT in the future.
- To look for any benefits for people with dementia, such as, improvements in quality of life, ability to carry out everyday tasks, mood, and brain blood flow.
How will the research be carried out?
- Forty patients with AzD, or mild cognitive impairment (MCI), and twenty healthy older adults will be recruited from memory and geriatric clinics, Join Dementia Research, general practice surgeries and community groups.
- Participants will be randomly assigned to brain training or control. The control group will be offered the program at the end of the study.
- First visit: Participants will complete questionnaires on quality of life, mood, everyday abilities, memory and an assessment of brain blood flow
- Brain training program: Participants will complete 15-30 minute sessions, 3-5 times per week
- Follow-up: participants will repeat the questionnaires and assessment of brain blood flow
- Interviews and feedback: to discuss how participants felt the program went, and find out if there are any ways it could be improved.
详细描述
Study design, recruitment
This will be a randomised clinical trial, undertaken at the University of Leicester, University Hospitals of Leicester (UHL) and Leicestershire Partnership National Health Service (NHS) Trusts (LPT). Following successful ethical approval, sponsorship, regulatory approvals, 40 participants with a diagnosis of MCI, or AzD, and 20 healthy volunteers will be recruited from memory clinics, general geriatric clinics, Join Dementia Research, community groups. Patients with a diagnosis of mild MCI, or mild to moderate AzD that are not under follow-up with the memory service will also be invited to participate in the study by letter invitation through their GP surgery.
Summary of the intervention
Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language.
First Visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy controls will be free of any medical co-morbidity or medication that could adversely affect cognition. Volunteers with well-controlled co-morbidities (i.e. hypertension, diabetes, will be considered for inclusion)
- •MCI as defined by National Institute on Aging and Alzheimer's Association (NIA-AA) 2011 and Petersen criteria
- •AzD as defined by the NIA-AA 2011 criteria
- •Deficits will be mild to moderate as defined by Montreal Cognitive Assessment (MoCA) score of 19-26 for MCI, and 9-18 for AzD (32-34).
- •Willing to participate
- •Capacity to consent to the study/personal consultee
- •Patients on and off anti-dementia medications will be included (acetylcholinesterase inhibitors, glutamate receptor antagonists)
- •Good understanding of written and spoken English
- •Age >50 years
- •Access to the internet and a computer/laptop or tablet device.
排除标准
- •Healthy controls with any medical co-morbidity or medication that could adversely affect cognition, or poorly controlled medical co-morbidities (i.e. hypertension, diabetes)
- •Unwilling to take part
- •Unable to consent/no personal consultee
- •Major medical co-morbidity; severe heart failure (ejection fraction <20%), carotid artery stenosis, severe respiratory disease, major stroke
- •Pregnancy, planning pregnancy, or lactating
- •Inadequate bilateral TCD windows
- •Participants already enrolled into other interventional studies
- •Insufficient understanding of written and spoken English
- •Age <50 years
- •No access to the internet and a computer/laptop or tablet device
结局指标
主要结局
Percentage of Participants Able to Successfully Complete the Minimum (15 Mins, 3x Per Week, for 8 Weeks) and Maximum (30 Mins, 5x Per Week, for 12 Weeks) Criteria CT Program and Complete All Assessments
时间窗: 17 months
Feasibility
Percentage of Participants With Full Bilateral Data for Cerebral Blood Flow Velocity (CBFv)
时间窗: 17 months
Feasibility CBFv as measured using transcranial Doppler ultrsonography (TCD)
Percentage of Control Participants Willing to be Randomised to Waiting List Control
时间窗: 17 months
Feasibility
Percentage of Participants Successfully Recruited
时间窗: 15 months
Feasibility
次要结局
- Change in Cognition Score as Detected by the Addenbrooke's Cognitive Examination (ACE-III) From Baseline to Follow-up at 12 Weeks(12 weeks)
- Change in Quality of Life Measure - Dementia Quality of Life Measure (DEMQOL) From Baseline to Follow-up at 12 Weeks(12 weeks)
- Change in Functional Status - Lawton Instrumental Activities of Daily Living (IADL) From Baseline to Follow-up at 12 Weeks(12 weeks)
- Change in Mood - Geriatric Depression Scale (GDS-15) From Baseline to Follow-up at 12 Weeks(12 weeks)
- Percentage Increase in Cerebral Blood Flow Velocity (CBFv) From Baseline to Follow-up at 12 Weeks(12 weeks)