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

Primary Purpose

Vascular Cognitive Impairment, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
tDCS
Exercise
Sham stimulation
Treatment as usual
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Cognitive Impairment focused on measuring transcranial direct current stimulation, tDCS, exercise, cognition, vascular cognitive impairment no dementia, vascular mild cognitive impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Other

Other

Arm Label

Exercise primed tDCS

Exercise primed Sham stimulation

Treatment as usual (exercise education) & tDCS

Treatment as usual (exercise education) & sham stimulation

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Behavioural measures
Behaviour will be measured with the Mild Behavioural Impairment-Checklist.

Full Information

First Posted
September 16, 2021
Last Updated
April 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05079464
Brief Title
Exercise as a Primer for Brain Stimulation in Vascular Cognitive Impairment No Dementia (VCIND)
Acronym
EXPRESS-V
Official Title
Exercise as a Primer for Excitatory Stimulation Study in Vascular Cognitive Impairment No Dementia (EXPRESS-V)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Cognitive Impairment, Mild Cognitive Impairment
Keywords
transcranial direct current stimulation, tDCS, exercise, cognition, vascular cognitive impairment no dementia, vascular mild cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, blinded, repeated-session, parallel-design study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, outcomes assessors, and investigators will be blinded to stimulation type.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise primed tDCS
Arm Type
Experimental
Arm Description
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
Arm Title
Exercise primed Sham stimulation
Arm Type
Other
Arm Description
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.
Arm Title
Treatment as usual (exercise education) & tDCS
Arm Type
Other
Arm Description
Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
Arm Title
Treatment as usual (exercise education) & sham stimulation
Arm Type
Other
Arm Description
Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
All participants randomized to tDCS will receive active tDCS
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants will exercise at Toronto Rehab.
Intervention Type
Other
Intervention Name(s)
Sham stimulation
Intervention Description
The same procedure for tDCS will be used for the sham condition, except without active current.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
Exercise education
Intervention Description
Exercise education/ treatment as usual will include routine advice about physical activity.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment - Global Cognition
Description
The Montreal Cognitive Assessment is a 5-minute test of global cognition and a validated tool for detecting early cognitive changes.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Cognitive domains
Description
Cognitive domains will be measured using the 60-minute battery recommended by the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network.
Time Frame
2 weeks
Title
Behavioural measures
Description
Behaviour will be measured with the Mild Behavioural Impairment-Checklist.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehreen Siddiqui
Phone
416-480-6100
Ext
63185
Email
mehreen.siddiqui@sri.utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Feng
Phone
416-480-6100
Ext
63185
Email
vivian.feng@sri.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Lanctôt, PhD
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehreen Siddiqui
Phone
416-480-6100
Ext
63185
Email
mehreen.siddiqui@sri.utoronto.ca

12. IPD Sharing Statement

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

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