Exercise as a Primer for Excitatory Stimulation Study in Vascular Cognitive Impairment No Dementia (EXPRESS-V)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment - Global Cognition
研究概览
简要总结
People with vascular conditions are at risk of having memory problems, and these memory problems increase the risk for further cognitive decline. Brain stimulation has been used to improve mood and memory. Transcranial direct current stimulation (tDCS) is believed to work best on brain cells that are active or "primed" before stimulation. The purpose of this study is to compare the effects of exercise and tDCS on memory performance in patients who have completed cardiac rehabilitation and are at risk of cognitive decline.
详细描述
Vascular disease is a major risk factor and contributor to dementia. Current interventions to manage vascular risk factors have mixed results. Presently, there are no consistently effective treatments targeting vascular cognitive impairment no dementia.
Study Aim: To evaluate the effect of exercise-primed tDCS on global cognition.
Study Design: Eligible participants will be randomized to one of four interventions: Exercise primer with tDCS, Treatment as usual (TAU/exercise education) with tDCS, or Exercise primer with sham tDCS, Treatment as usual with sham tDCS. Participants randomized to an exercise group will undergo exercise, followed by either sham or active tDCS. Participants randomized to TAU will receive written information in accordance with the Canadian Physical Activity Guidelines for older adults and tDCS or sham. Cognition, behaviour, neuroimaging and blood biomarkers will be measured.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, outcomes assessors, and investigators will be blinded to stimulation type.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 years of age; females must be post-menopausal
- •Presence of cerebrovascular and/or cardiovascular risk factors or coronary artery disease
- •Montreal Cognitive Assessment (MoCA) <27
- •Sufficiently proficient in English
- •Must be able to exercise at a moderate intensity level
- •Presence of modest deficits (1 standard deviation below population norm) in one of the following domains: executive function, verbal memory, working memory, or visuospatial memory
排除标准
- •History of stroke
- •Change in psychotropics within the last 4 weeks
- •Current benzodiazepine use due
- •Metal implants that would preclude safe use of tDCS or neuroimaging
- •Significant neurological or psychiatric conditions (current major depressive disorder, bipolar disorder, schizophrenia)
- •MoCA <18 and/or clinical diagnosis of dementia
- •Any medical contraindications to exercise
研究组 & 干预措施
Exercise primed tDCS
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
干预措施: tDCS (Other)
Exercise primed tDCS
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
干预措施: Exercise (Other)
Exercise primed Sham stimulation
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.
干预措施: Exercise (Other)
Exercise primed Sham stimulation
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.
干预措施: Sham stimulation (Other)
Treatment as usual (exercise education) & tDCS
Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
干预措施: tDCS (Other)
Treatment as usual (exercise education) & sham stimulation
Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
干预措施: Sham stimulation (Other)
Treatment as usual (exercise education) & tDCS
Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
干预措施: Treatment as usual (Other)
Treatment as usual (exercise education) & sham stimulation
Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Montreal Cognitive Assessment - Global Cognition
时间窗: 2 weeks
The Montreal Cognitive Assessment is a 5-minute test of global cognition and a validated tool for detecting early cognitive changes.
次要结局
- Cognitive domains(2 weeks)
- Behavioural measures(2 weeks)