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

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Vascular Cognitive Impairment; Mild Cognitive Impairment

Treatments: Other: Sham stimulation; Other: Exercise; Other: tDCS; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05079464

3348

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 4 patient groups

Exercise primed tDCS

Experimental group

Description:

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

Treatment:

Other: tDCS

Other: Exercise

Exercise primed Sham stimulation

Other group

Description:

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

Treatment:

Other: Sham stimulation

Other: Exercise

Treatment as usual (exercise education) & tDCS

Other group

Description:

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

Treatment:

Other: Treatment as usual

Other: tDCS

Treatment as usual (exercise education) & sham stimulation

Other group

Description:

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

Treatment:

Other: Treatment as usual

Other: Sham stimulation