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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and tDCS | Experimental | Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention. |
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| Exercise Education and tDCS | Other | Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention. |
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| Exercise and Sham tDCS | Other | Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Other | All study participants randomized to tDCS will receive active tDCS. |
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| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3) | Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome. | Study endpoint (two-weeks post baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| n-back reaction time at study endpoint (T3) | A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome. | Study endpoint (two-weeks post baseline) |
| Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of blood biomarkers of brain plasticity at study endpoint (T3) | Biomarkers associated with exercise, tDCS outcomes, angiogenesis and neurogenesis will be obtained from blood work and analyzed using enzyme linked immunosorbent assays. | Study endpoint (two-weeks post baseline) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M3H0A7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863115 | Derived | 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. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D015444 | Exercise |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
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This is a randomized, blinded, repeated-session, parallel-design study.
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The research personnel that will be administering the cognitive assessments will be blinded to treatment allocation. The patients will be blinded to stimulation type.
| Exercise | Other | Participants will exercise at TRI according to an individualized exercise prescription. |
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| Exercise Education | Other | Exercise education/ treatment as usual will include routine advice about physical activity for older adults. |
|
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| Sham tDCS | Other | The same procedure for tDCS will be used for the sham condition, except without active current. |
|
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. |
| Study endpoint (two-weeks post baseline) |
| The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3) | 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. | Study endpoint (two-weeks post baseline) |
| The Neuropsychiatric Inventory (NPI) at study endpoint (T3) | 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. | Study endpoint (two-weeks post baseline) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |