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NCT Number: NCT05079464

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

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Mehreen Siddiqui

CONTACT

[email protected]

416-480-6100 ext. 63185

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Other

All participants randomized to tDCS will receive active tDCS

Exercise

Other

Participants will exercise at Toronto Rehab.

Sham stimulation

Other

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

Treatment as Usual

Other

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

Other names: Exercise education

Primary outcomes

  1. Montreal Cognitive Assessment - Global Cognition

    Time frame: 2 weeks

    The Montreal Cognitive Assessment is a 5-minute test of global cognition and a validated tool for detecting early cognitive changes.

Secondary outcomes

  1. Cognitive domains

    Time frame: 2 weeks

    Cognitive domains will be measured using the 60-minute battery recommended by the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network.

  2. Behavioural measures

    Time frame: 2 weeks

    Behaviour will be measured with the Mild Behavioural Impairment-Checklist.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Survilla

CONTACT

[email protected]

416-480-6100 ext. 63185

Mehreen Siddiqui

CONTACT

[email protected]

416-480-6100 ext. 63185

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: EXPRESS-V

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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