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

April 10, 2026 updated by: Sunnybrook Health Sciences Centre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise primed tDCS
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
Other: tDCS
All participants randomized to tDCS will receive active tDCS
Other: Exercise
Participants will exercise at Toronto Rehab.
Other: Exercise primed Sham stimulation
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.
Other: Exercise
Participants will exercise at Toronto Rehab.
Other: Sham stimulation
The same procedure for tDCS will be used for the sham condition, except without active current.
Other: Treatment as usual (exercise education) & tDCS
Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
Other: tDCS
All participants randomized to tDCS will receive active tDCS
Other: Treatment as usual
Exercise education/ treatment as usual will include routine advice about physical activity.
Other Names:
  • Exercise education
Other: Treatment as usual (exercise education) & sham stimulation
Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
Other: Sham stimulation
The same procedure for tDCS will be used for the sham condition, except without active current.
Other: Treatment as usual
Exercise education/ treatment as usual will include routine advice about physical activity.
Other Names:
  • Exercise education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 weeks
Behavioural measures
Time Frame: 2 weeks
Behaviour will be measured with the Mild Behavioural Impairment-Checklist.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Krista Lanctôt, PhD, Sunnybrook Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3348

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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