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

Not Applicable

Recruiting

• Conditions: Vascular Cognitive Impairment; Mild Cognitive Impairment
• Interventions: Other: tDCS; Other: Exercise; Other: Sham stimulation; Other: Treatment as usual

• Registration Number: NCT05079464
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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. 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 Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-15
• Study Start: 2021-11-22
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise primed tDCS	Exercise	Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
Exercise primed Sham stimulation	Exercise	Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.
Exercise primed tDCS	tDCS	Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
Exercise primed Sham stimulation	Sham stimulation	Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.
Treatment as usual (exercise education) & sham stimulation	Sham stimulation	Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
Treatment as usual (exercise education) & tDCS	Treatment as usual	Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
Treatment as usual (exercise education) & sham stimulation	Treatment as usual	Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
Treatment as usual (exercise education) & tDCS	tDCS	Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment - Global Cognition	2 weeks	The Montreal Cognitive Assessment is a 5-minute test of global cognition and a validated tool for detecting early cognitive changes.

Secondary Outcome Measures

Name	Time	Method
Cognitive domains	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.
Behavioural measures	2 weeks	Behaviour will be measured with the Mild Behavioural Impairment-Checklist.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada