Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2025-08-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, blinded, repeated-session, parallel-design study.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The research personnel that will be administering the cognitive assessments will be blinded to treatment allocation. The patients will be blinded to stimulation type.

Study Groups

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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.

Group Type EXPERIMENTAL

tDCS

Intervention Type OTHER

All study participants randomized to tDCS will receive active tDCS.

Exercise

Intervention Type OTHER

Participants will exercise at TRI according to an individualized exercise prescription.

Exercise Education and tDCS

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

Group Type OTHER

tDCS

Intervention Type OTHER

All study participants randomized to tDCS will receive active tDCS.

Exercise Education

Intervention Type OTHER

Exercise education/ treatment as usual will include routine advice about physical activity for older adults.

Exercise and Sham tDCS

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

Group Type OTHER

Exercise

Intervention Type OTHER

Participants will exercise at TRI according to an individualized exercise prescription.

Sham tDCS

Intervention Type OTHER

The same procedure for tDCS will be used for the sham condition, except without active current.

Interventions

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tDCS

All study participants randomized to tDCS will receive active tDCS.

Intervention Type OTHER

Exercise

Participants will exercise at TRI according to an individualized exercise prescription.

Intervention Type OTHER

Exercise Education

Exercise education/ treatment as usual will include routine advice about physical activity for older adults.

Intervention Type OTHER

Sham tDCS

The same procedure for tDCS will be used for the sham condition, except without active current.

Intervention Type OTHER

Other Intervention Names

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Treatment as usual

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No