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

March 25, 2024 updated by: Sunnybrook Health Sciences Centre

Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3H0A7
        • Recruiting
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise and tDCS
Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.
Other: tDCS
All study participants randomized to tDCS will receive active tDCS.
Other: Exercise
Participants will exercise at TRI according to an individualized exercise prescription.
Other: Exercise Education and tDCS
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
Other: tDCS
All study participants randomized to tDCS will receive active tDCS.
Other: Exercise Education
Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
Other Names:
  • Treatment as usual
Other: Exercise and Sham tDCS
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Other: Exercise
Participants will exercise at TRI according to an individualized exercise prescription.
Other: Sham tDCS
The same procedure for tDCS will be used for the sham condition, except without active current.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)
Time Frame: Change over 2 weeks (Baseline to Endpoint)
Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.
Change over 2 weeks (Baseline to Endpoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognition: n-back reaction time
Time Frame: Change over 2 weeks (Baseline to Endpoint)
A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.
Change over 2 weeks (Baseline to Endpoint)
Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)
Time Frame: Change over 2 weeks (Baseline to Endpoint)
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 over 2 weeks (Baseline to Endpoint)
Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores
Time Frame: Change over 2 weeks Baseline to Endpoint
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 over 2 weeks Baseline to Endpoint
Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI)
Time Frame: Change over 2 weeks (Baseline to Endpoint)
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.
Change over 2 weeks (Baseline to Endpoint)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in concentration of blood biomarkers of brain plasticity
Time Frame: Change over 2 weeks (Baseline to Endpoint)
Biomarkers associated with exercise, tDCS outcomes, angiogenesis and neurogenesis will be obtained from blood work and analyzed using enzyme linked immunosorbent assays.
Change over 2 weeks (Baseline to Endpoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 075-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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