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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Vascular Cognitive Impairment Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, blinded, repeated-session, parallel-design study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants, outcomes assessors, and investigators will be blinded to stimulation type.

Study Groups

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Exercise primed tDCS

Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.

Group Type EXPERIMENTAL

tDCS

Intervention Type OTHER

All participants randomized to tDCS will receive active tDCS

Exercise

Intervention Type OTHER

Participants will exercise at Toronto Rehab.

Exercise primed Sham stimulation

Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.

Group Type OTHER

Exercise

Intervention Type OTHER

Participants will exercise at Toronto Rehab.

Sham stimulation

Intervention Type OTHER

The same procedure for tDCS will be used for the sham condition, except without active current.

Treatment as usual (exercise education) & tDCS

Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.

Group Type OTHER

tDCS

Intervention Type OTHER

All participants randomized to tDCS will receive active tDCS

Treatment as usual

Intervention Type OTHER

Exercise education/ treatment as usual will include routine advice about physical activity.

Treatment as usual (exercise education) & sham stimulation

Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.

Group Type OTHER

Sham stimulation

Intervention Type OTHER

The same procedure for tDCS will be used for the sham condition, except without active current.

Treatment as usual

Intervention Type OTHER

Exercise education/ treatment as usual will include routine advice about physical activity.

Interventions

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tDCS

All participants randomized to tDCS will receive active tDCS

Intervention Type OTHER

Exercise

Participants will exercise at Toronto Rehab.

Intervention Type OTHER

Sham stimulation

The same procedure for tDCS will be used for the sham condition, except without active current.

Intervention Type OTHER

Treatment as usual

Exercise education/ treatment as usual will include routine advice about physical activity.

Intervention Type OTHER

Other Intervention Names

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Exercise education

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No