Exercise as a Primer for Brain Stimulation in Vascular Cognitive Impairment No Dementia (VCIND)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise as a Primer for Excitatory Stimulation Study in Vascular Cognitive Impairment No Dementia (EXPRESS-V)

Conditions
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Vascular Cognitive Impairment, Mild Cognitive Impairment

Intervention / Treatment
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* Other: tDCS
* Other: Exercise
* Other: Sham stimulation
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, blinded, repeated-session, parallel-design study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise primed tDCS<br>Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS. | Other: tDCS<br>* All participants randomized to tDCS will receive active tDCS<br>Other: Exercise<br>* Participants will exercise at Toronto Rehab.<br>|
| Other: Exercise primed Sham stimulation<br>Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS. | Other: Exercise<br>* Participants will exercise at Toronto Rehab.<br>Other: Sham stimulation<br>* The same procedure for tDCS will be used for the sham condition, except without active current.<br>|
| Other: Treatment as usual (exercise education) & tDCS<br>Individuals randomized to this group will receive routine advice about physical activity, and active tDCS. | Other: tDCS<br>* All participants randomized to tDCS will receive active tDCS<br>Other: Treatment as usual<br>* Exercise education/ treatment as usual will include routine advice about physical activity.<br>* Other names: Exercise education;|
| Other: Treatment as usual (exercise education) & sham stimulation<br>Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS. | Other: Sham stimulation<br>* The same procedure for tDCS will be used for the sham condition, except without active current.<br>Other: Treatment as usual<br>* Exercise education/ treatment as usual will include routine advice about physical activity.<br>* Other names: Exercise education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment - Global Cognition | The Montreal Cognitive Assessment is a 5-minute test of global cognition and a validated tool for detecting early cognitive changes. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive domains | Cognitive domains will be measured using the 60-minute battery recommended by the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network. | 2 weeks | 
| Behavioural measures | Behaviour will be measured with the Mild Behavioural Impairment-Checklist. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, transcranial direct current stimulation, exercise, cognition, vascular cognitive impairment no dementia, vascular mild cognitive impairment