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Recruiting NCT05079464

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

No phase Interventional Vascular Cognitive Impairment Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tDCS, Exercise, Sham stimulation, Treatment as usual.
Who it may be relevant to
Registry conditions: Vascular Cognitive Impairment, Mild Cognitive Impairment. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other tDCS
    All participants randomized to tDCS will receive active 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/ treatment as usual will include routine advice about physical activity.

Primary outcome measures

  • Montreal Cognitive Assessment - Global Cognition [Time frame: 2 weeks]
Secondary outcome measures (2)
  • Cognitive domains [Time frame: 2 weeks]
  • Behavioural measures [Time frame: 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Sunnybrook Health Sciences Centre — Toronto

Identifiers

NCT: NCT05079464 · 3348

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗