Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia

NCT03670615 | Completed

• 1 other identifier: 075-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Alzheimer disease; cognition; transcranial direct current stimulation; exercise; mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)

  Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.

  Study endpoint (two-weeks post baseline)

Secondary Outcomes (4)

• 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)

Other Outcomes (1)

• Concentration of blood biomarkers of brain plasticity at study endpoint (T3)

  Study endpoint (two-weeks post baseline)

Study Arms (3)

Exercise and tDCS

EXPERIMENTAL

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

Other: tDCS; Other: Exercise

Exercise Education and tDCS

OTHER

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

Other: tDCS; Other: Exercise Education

Exercise and Sham tDCS

OTHER

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

Other: Exercise; Other: Sham tDCS

Interventions

tDCS OTHER

All study participants randomized to tDCS will receive active tDCS.

Exercise Education and tDCS; Exercise and tDCS

Exercise OTHER

Participants will exercise at TRI according to an individualized exercise prescription.

Exercise and Sham tDCS; Exercise and tDCS

Exercise Education OTHER

Exercise education/ treatment as usual will include routine advice about physical activity for older adults.

Also known as: Treatment as usual

Exercise Education and tDCS

Sham tDCS OTHER

The same procedure for tDCS will be used for the sham condition, except without active current.

Exercise and Sham tDCS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M3H0A7, Canada

Location

Related Publications (1)

• 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.

  PMID: 34863115 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Motor Activity

Interventions

Transcranial Direct Current Stimulation; Exercise; Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research personnel that will be administering the cognitive assessments will be blinded to treatment allocation. The patients will be blinded to stimulation type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, blinded, repeated-session, parallel-design study.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 13, 2018
• Study Start: November 28, 2018
• Primary Completion: August 1, 2025
• Study Completion: August 6, 2025
• Last Updated: March 30, 2026

Record last verified: 2025-05

Locations

CA (1)