Vascular Cognitive ImpairmentEXPRESS-VNCT05079464
Exercise as a Primer for Brain Stimulation in Vascular Cognitive Impairment No Dementia (VCIND)
A study testing tDCS, Exercise and Treatment as usual in people with Vascular Cognitive Impairment and Mild Cognitive Impairment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vascular Cognitive Impairment, Mild Cognitive Impairment
- What is being tested?
- tDCS, Exercise and Treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mehreen Siddiqui, 416-480-6100 ext. 63185, mehreen.siddiqui@sri.utoronto.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- tDCS, Exercise, Sham stimulation, Treatment as usual
- Keywords
- transcranial direct current stimulation, tDCS, exercise, cognition, vascular cognitive impairment no dementia, vascular mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
All participants randomized to tDCS will receive active tDCS
ExerciseOther
Participants will exercise at Toronto Rehab.
Sham stimulationOther
The same procedure for tDCS will be used for the sham condition, except without active current.
Treatment as usualOther
Also called Exercise education
Exercise education/ treatment as usual will include routine advice about physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Exercise primed tDCS | Experimental | Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS. Receives: Other: tDCS; Other: Exercise |
| Exercise primed Sham stimulation | Other | Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS. Receives: Other: Exercise; Other: Sham stimulation |
| Treatment as usual (exercise education) & tDCS | Other | Individuals randomized to this group will receive routine advice about physical activity, and active tDCS. Receives: Other: tDCS; Other: Treatment as usual |
| Treatment as usual (exercise education) & sham stimulation | Other | Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS. Receives: Other: Sham stimulation; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
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.
Measured: 2 weeks
Behavioural measures
Behaviour will be measured with the Mild Behavioural Impairment-Checklist.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start22 Nov 2021
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded, repeated-session, parallel-design study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista Lanctôt, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079464
- Sponsor's protocol ID
- 3348
- Acronym
- EXPRESS-V
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as a Primer for Excitatory Stimulation Study in Vascular Cognitive Impairment No Dementia (EXPRESS-V)
- ClinicalTrials.gov ID
- NCT05079464
- Acronym / sponsor ID
- EXPRESS-V / 3348
- Keywords
- transcranial direct current stimulation, tDCS, exercise, cognition, vascular cognitive impairment no dementia, vascular mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, blinded, repeated-session, parallel-design study
| Arm | Type | Receives |
|---|---|---|
| Exercise primed tDCS | Experimental | Other: tDCS, Other: ExerciseIndividuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS. |
| Exercise primed Sham stimulation | Other | Other: Exercise, Other: Sham stimulationIndividuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS. |
| Treatment as usual (exercise education) & tDCS | Other | Other: tDCS, Other: Treatment as usualIndividuals randomized to this group will receive routine advice about physical activity, and active tDCS. |
| Treatment as usual (exercise education) & sham stimulation | Other | Other: Sham stimulation, Other: Treatment as usualIndividuals randomized to this group will receive routine advice about physical activity, and sham tDCS. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAll participants randomized to tDCS will receive active tDCS | Other | Exercise primed tDCS, Treatment as usual (exercise education) & tDCS |
| ExerciseParticipants will exercise at Toronto Rehab. | Other | Exercise primed Sham stimulation, Exercise primed tDCS |
| Sham stimulationThe same procedure for tDCS will be used for the sham condition, except without active current. | Other | Exercise primed Sham stimulation, Treatment as usual (exercise education) & sham stimulation |
| Treatment as usualAlso: Exercise educationExercise education/ treatment as usual will include routine advice about physical activity. | Other | Treatment as usual (exercise education) & sham stimulation, Treatment as usual (exercise education) & tDCS |
Primary outcome
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 secondary outcomes
Cognitive domains
Time frame: 2 weeks
Behavioural measures
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krista Lanctôt, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS, Exercise and Treatment as usual in people with Vascular Cognitive Impairment and Mild Cognitive Impairment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehreen Siddiqui (416-480-6100 ext. 63185, mehreen.siddiqui@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment - Global Cognition (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.