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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

64

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Sunnybrook Health Sciences Centre

Investigators

  • 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)

November 22, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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