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

Mild Cognitive Impairment Clinical Trial

— EXPRESS-V  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079464
• Other study ID #: 3348
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Mehreen Siddiqui
• Phone: 416-480-6100
• Email: mehreen.siddiqui[@]sri.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Vascular Cognitive Impairment

Intervention

Other:
• tDCS
All participants randomized to tDCS will receive active tDCS
• Exercise
Participants will exercise at Toronto Rehab.
• Sham stimulation
The same procedure for tDCS will be used for the sham condition, except without active current.
• Treatment as usual
Exercise education/ treatment as usual will include routine advice about physical activity.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	Behavioural measures	Behaviour will be measured with the Mild Behavioural Impairment-Checklist.	2 weeks