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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05079464

Collaborator

(none)

Enrollment

Location

Arms

33.3

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Cognitive Impairment Mild Cognitive Impairment	Other: tDCS Other: Exercise Other: Sham stimulation Other: Treatment as usual	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, blinded, repeated-session, parallel-design studyRandomized, blinded, repeated-session, parallel-design study

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Participants, outcomes assessors, and investigators will be blinded to stimulation type.

Primary Purpose:

Treatment

Official Title:

Exercise as a Primer for Excitatory Stimulation Study in Vascular Cognitive Impairment No Dementia (EXPRESS-V)

Actual Study Start Date :

Nov 22, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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