Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes 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.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: tDCS (Other)
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.
Intervention: Exercise (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.
Intervention: tDCS (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.
Intervention: Exercise Education (Other)
Exercise and Sham tDCS
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Intervention: Exercise (Other)
Exercise and Sham tDCS
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Intervention: Sham tDCS (Other)
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)
Time Frame: Study endpoint (two-weeks post baseline)
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
- n-back reaction time at study endpoint (T3)(Study endpoint (two-weeks post baseline))
- Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3)(Study endpoint (two-weeks post baseline))
- The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3)(Study endpoint (two-weeks post baseline))
- The Neuropsychiatric Inventory (NPI) at study endpoint (T3)(Study endpoint (two-weeks post baseline))