Exercise as a Primer for Brain Stimulation in Vascular Cognitive Impairment No Dementia (VCIND)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
Other interventionAll participants randomized to tDCS will receive active tDCS
Exercise
Other interventionParticipants will exercise at Toronto Rehab.
Sham stimulation
Other interventionThe same procedure for tDCS will be used for the sham condition, except without active current.
Treatment as usual
Other interventionExercise education/ treatment as usual will include routine advice about physical activity.
Treatment groups
64 Participants
are divided into 4 treatment groupsGroup A: Exercise primed tDCSExperimental treatment 2 interventions
Group B: Exercise primed Sham stimulationOther 2 interventions
Group C: Treatment as usual (exercise education) & tDCSOther 2 interventions
Group D: Treatment as usual (exercise education) & sham stimulationOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeksSecondary outcomes
1
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.
Time frame
2 weeks2
Behavioural measures
Behaviour will be measured with the Mild Behavioural Impairment-Checklist.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov