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

NCT05079464 | Recruiting

• 1 other identifier: 3348
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Cognitive Impairment; Mild Cognitive Impairment

Keywords

transcranial direct current stimulation; tDCS; exercise; cognition; vascular cognitive impairment no dementia; vascular mild cognitive impairment

Outcome Measures

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.

  2 weeks

Secondary Outcomes (2)

• Cognitive domains

  2 weeks

• Behavioural measures

  2 weeks

Study Arms (4)

Exercise primed tDCS

EXPERIMENTAL

Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.

Other: tDCS; Other: Exercise

Exercise primed Sham stimulation

OTHER

Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.

Other: Exercise; Other: Sham stimulation

Treatment as usual (exercise education) & tDCS

OTHER

Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.

Other: tDCS; Other: Treatment as usual

Treatment as usual (exercise education) & sham stimulation

OTHER

Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.

Other: Sham stimulation; Other: Treatment as usual

Interventions

tDCS OTHER

All participants randomized to tDCS will receive active tDCS

Exercise primed tDCS; Treatment as usual (exercise education) & tDCS

Exercise OTHER

Participants will exercise at Toronto Rehab.

Exercise primed Sham stimulation; Exercise primed tDCS

Sham stimulation OTHER

The same procedure for tDCS will be used for the sham condition, except without active current.

Exercise primed Sham stimulation; Treatment as usual (exercise education) & sham stimulation

Treatment as usual OTHER

Exercise education/ treatment as usual will include routine advice about physical activity.

Also known as: Exercise education

Treatment as usual (exercise education) & sham stimulation; Treatment as usual (exercise education) & tDCS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Transcranial Direct Current Stimulation; Exercise; Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Krista Lanctôt, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehreen Siddiqui

CONTACT

416-480-6100; mehreen.siddiqui@sri.utoronto.ca

Kate Survilla

CONTACT

416-480-6100; kate.survilla@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, outcomes assessors, and investigators will be blinded to stimulation type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, repeated-session, parallel-design study

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 15, 2021
• Study Start: November 22, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CA (1)