Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in cognition: n-back reaction time(Change over 2 weeks (Baseline to Endpoint))
- Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores(Change over 2 weeks Baseline to Endpoint)
- Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)(Change over 2 weeks (Baseline to Endpoint))
- Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI)(Change over 2 weeks (Baseline to Endpoint))