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Behavioural Intervention

Exercise + Brain Stimulation for Vascular Cognitive Impairment (EXPRESS-V Trial)

N/A
Recruiting
Led By Krista Lanctôt, PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥50 years of age; females must be post-menopausal
Presence of cerebrovascular and/or cardiovascular risk factors or coronary artery disease
Must not have
Current benzodiazepine use
History of stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of exercise and brain stimulation on memory in patients who have completed cardiac rehab and are at risk for cognitive decline.

Who is the study for?
This trial is for English-speaking adults over 50, especially post-menopausal women, with cardiovascular risks or disease and mild memory issues. They must be able to exercise moderately but can't have had a stroke, recent psychotropic medication changes, benzodiazepine use, metal implants affecting brain stimulation safety, or significant neurological/psychiatric conditions.
What is being tested?
The study tests if exercising before brain stimulation (tDCS) improves memory in those at risk of cognitive decline after cardiac rehab. It compares the combination of exercise and tDCS against sham stimulation and usual treatment to see which is more effective.
What are the potential side effects?
Possible side effects may include discomfort from the tDCS device like itching or tingling on the scalp, fatigue from moderate exercise, and potential muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 50 and, if female, I am post-menopausal.
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I have heart disease or risk factors for stroke or heart disease.
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My cognitive test score is below 27.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking benzodiazepines.
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I have had a stroke in the past.
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I have been diagnosed with dementia or scored less than 18 on the MoCA test.
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I do not have major depression, bipolar disorder, or schizophrenia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montreal Cognitive Assessment - Global Cognition
Secondary study objectives
Behavioural measures
Cognitive domains

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment as usual (exercise education) & tDCSExperimental Treatment2 Interventions
Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
Group II: Treatment as usual (exercise education) & sham stimulationExperimental Treatment2 Interventions
Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
Group III: Exercise primed tDCSExperimental Treatment2 Interventions
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
Group IV: Exercise primed Sham stimulationExperimental Treatment2 Interventions
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,678 Total Patients Enrolled
Krista Lanctôt, PhDPrincipal InvestigatorSunnybrook Research Institute
2 Previous Clinical Trials
221 Total Patients Enrolled

Media Library

Exercise (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05079464 — N/A
Mild Cognitive Impairment Research Study Groups: Exercise primed Sham stimulation, Treatment as usual (exercise education) & sham stimulation, Treatment as usual (exercise education) & tDCS, Exercise primed tDCS
Mild Cognitive Impairment Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05079464 — N/A
Exercise (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05079464 — N/A
~14 spots leftby Sep 2025
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