Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia (EXACT)

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Treatments: Other: tDCS; Other: Exercise; Other: Exercise Education; Other: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03670615

075-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Exercise and tDCS

Experimental group

Description:

Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.

Treatment:

Other: Exercise

Other: tDCS

Exercise Education and tDCS

Other group

Description:

Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.

Treatment:

Other: Exercise Education

Other: tDCS

Exercise and Sham tDCS

Other group

Description:

Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.

Treatment:

Other: Sham tDCS

Other: Exercise