Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia
- Conditions
- Mild Cognitive ImpairmentAlzheimer Disease
- Interventions
- Other: tDCSOther: Sham tDCSOther: ExerciseOther: Exercise Education
- Registration Number
- NCT03670615
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise and Sham tDCS Sham tDCS Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention. Exercise and tDCS 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. Exercise and tDCS Exercise Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention. Exercise Education and tDCS tDCS Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention. Exercise Education and tDCS Exercise Education Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention. Exercise and Sham tDCS Exercise Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
- Primary Outcome Measures
Name Time Method Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) 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 Outcome Measures
Name Time Method Change in cognition: n-back reaction time 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 in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores 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 in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) 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 in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI) 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.
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada