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Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia (EXACT)

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease

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

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Alzheimer disease, cognition, transcranial direct current stimulation, exercise, mild cognitive impairment

Eligibility Criteria

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

Inclusion Criteria:

  • Males or females ≥50 years of age
  • DSM-5 criteria for major or mild neurocognitive disorder due to AD or mixed AD/vascular disease
  • Mild severity of impairment (standardized Mini-Mental State Examination (MMSE) score ≥19)
  • Read and communicate in English

Exclusion Criteria:

  • Change in cognitive enhancing medications (ChEIs and/or memantine) less than 3 months prior to study screen
  • Change in anticonvulsants or psychotropic medications less than 1 month prior to study screen
  • Currently taking benzodiazepines
  • Presence of metal implants that would preclude safe use of tDCS (e.g. pace-maker)
  • Significant neurological condition (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
  • Current psychiatric disorders (e.g. schizophrenia, bipolar disorder, depression, psychosis) or current substance use disorder
  • Medical contraindications to increasing activity level according to the Canadian Society of Exercise Physiology Questionnaire

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Exercise and tDCS

Exercise Education and tDCS

Exercise and Sham tDCS

Arm Description

Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.

Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.

Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.

Outcomes

Primary Outcome Measures

Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)
Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.

Secondary Outcome Measures

Change in cognition: n-back reaction time
A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.
Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)
Assesses recall memory. Number of words not recalled will be tallied. Word recall scores range from 0 to 10. Higher scores represent a worse outcome.
Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores
A brief measure of global cognition that includes assessments of orientation, short-term total memory, executive function, language abilities, attention and visuospatial ability. MoCA scores range from 0 to 30. Higher scores represent a better outcome.
Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI)
A widely used assessment of behavior disturbances in dementia including: apathy, agitation, delusions, hallucinations, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, and eating. Frequency and severity of each symptom is measured using subscales. Frequency and severity are judged using a 4-point scale (ranging from 1-4) and 3-point scale (ranging from 1-3) respectively. A 6-point scale for each symptom is used to evaluate caregiver distress (ranging from 0-5). Higher values represent a worse outcome.

Full Information

First Posted
August 22, 2018
Last Updated
February 10, 2023
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03670615
Brief Title
Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia
Acronym
EXACT
Official Title
Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
February 2025 (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
Mild cognitive impairment and Alzheimer's disease are conditions that involve memory difficulties. Transcranial direct current stimulation is a type of brain stimulation. It may help improve these memory difficulties. However, it works better on active brain areas. This study looks at if combining exercise and applying current to important parts of the brain can help improve memory in people with Mild Cognitive Impairment or Alzheimer's disease.
Detailed Description
Objectives: To assess the efficacy of a combined exercise and tDCS treatment for improving cognitive outcomes in mild cognitive impairment and mild Alzheimer's disease. Study Design: Eligible participants will be randomized to one of three interventions: Exercise and tDCS, Treatment as usual (TAU/exercise education) and tDCS, or Exercise and 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 for the same duration. Cognition, neuropsychiatric symptoms and blood samples for biomarker analysis will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease
Keywords
Alzheimer disease, cognition, transcranial direct current stimulation, exercise, mild cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, blinded, repeated-session, parallel-design study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The research personnel that will be administering the cognitive assessments will be blinded to treatment allocation. The patients will be blinded to stimulation type.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and tDCS
Arm Type
Experimental
Arm Description
Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.
Arm Title
Exercise Education and tDCS
Arm Type
Other
Arm Description
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
Arm Title
Exercise and Sham tDCS
Arm Type
Other
Arm Description
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
All study participants randomized to tDCS will receive active tDCS.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants will exercise at TRI according to an individualized exercise prescription.
Intervention Type
Other
Intervention Name(s)
Exercise Education
Other Intervention Name(s)
Treatment as usual
Intervention Description
Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
Intervention Type
Other
Intervention Name(s)
Sham tDCS
Intervention Description
The same procedure for tDCS will be used for the sham condition, except without active current.
Primary Outcome Measure Information:
Title
Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)
Description
Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.
Time Frame
Change over 2 weeks (Baseline to Endpoint)
Secondary Outcome Measure Information:
Title
Change in cognition: n-back reaction time
Description
A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.
Time Frame
Change over 2 weeks (Baseline to Endpoint)
Title
Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)
Description
Assesses recall memory. Number of words not recalled will be tallied. Word recall scores range from 0 to 10. Higher scores represent a worse outcome.
Time Frame
Change over 2 weeks (Baseline to Endpoint)
Title
Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores
Description
A brief measure of global cognition that includes assessments of orientation, short-term total memory, executive function, language abilities, attention and visuospatial ability. MoCA scores range from 0 to 30. Higher scores represent a better outcome.
Time Frame
Change over 2 weeks Baseline to Endpoint
Title
Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI)
Description
A widely used assessment of behavior disturbances in dementia including: apathy, agitation, delusions, hallucinations, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, and eating. Frequency and severity of each symptom is measured using subscales. Frequency and severity are judged using a 4-point scale (ranging from 1-4) and 3-point scale (ranging from 1-3) respectively. A 6-point scale for each symptom is used to evaluate caregiver distress (ranging from 0-5). Higher values represent a worse outcome.
Time Frame
Change over 2 weeks (Baseline to Endpoint)
Other Pre-specified Outcome Measures:
Title
Changes in concentration of blood biomarkers of brain plasticity
Description
Biomarkers associated with exercise, tDCS outcomes, angiogenesis and neurogenesis will be obtained from blood work and analyzed using enzyme linked immunosorbent assays.
Time Frame
Change over 2 weeks (Baseline to Endpoint)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females ≥50 years of age DSM-5 criteria for major or mild neurocognitive disorder due to AD or mixed AD/vascular disease Mild severity of impairment (standardized Mini-Mental State Examination (MMSE) score ≥19) Read and communicate in English Exclusion Criteria: Change in cognitive enhancing medications (ChEIs and/or memantine) less than 3 months prior to study screen Change in anticonvulsants or psychotropic medications less than 1 month prior to study screen Currently taking benzodiazepines Presence of metal implants that would preclude safe use of tDCS (e.g. pace-maker) Significant neurological condition (e.g. epilepsy, Parkinson's disease, multiple sclerosis) Current psychiatric disorders (e.g. schizophrenia, bipolar disorder, depression, psychosis) or current substance use disorder Medical contraindications to increasing activity level according to the Canadian Society of Exercise Physiology Questionnaire
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
Ella Song
Phone
416-480-6100
Ext
63185
Email
bing.song@sri.utoronto.ca
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H0A7
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
34863115
Citation
Liu CS, Herrmann N, Song BX, Ba J, Gallagher D, Oh PI, Marzolini S, Rajji TK, Charles J, Papneja P, Rapoport MJ, Andreazza AC, Vieira D, Kiss A, Lanctot KL. Exercise priming with transcranial direct current stimulation: a study protocol for a randomized, parallel-design, sham-controlled trial in mild cognitive impairment and Alzheimer's disease. BMC Geriatr. 2021 Dec 4;21(1):677. doi: 10.1186/s12877-021-02636-6.
Results Reference
derived

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Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia

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