Clinical trial NCT03670615: Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia
Official title: Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: Alzheimer disease
cognition
transcranial direct current stimulation
exercise
mild cognitive impairment
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, blinded, repeated-session, parallel-design study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)
timeFrame: Change over 2 weeks (Baseline to Endpoint)
Secondary outcomes:
measure: Change in cognition: n-back reaction time
timeFrame: Change over 2 weeks (Baseline to Endpoint)
measure: Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)
timeFrame: Change over 2 weeks (Baseline to Endpoint)
measure: Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores
timeFrame: Change over 2 weeks Baseline to Endpoint
measure: Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI)
timeFrame: Change over 2 weeks (Baseline to Endpoint)
Other outcomes:
measure: Changes in concentration of blood biomarkers of brain plasticity
timeFrame: Change over 2 weeks (Baseline to Endpoint)
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
citation: 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.