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

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ClinicalTrials.gov Identifier: NCT03670615
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Disease Other: tDCS Other: Exercise Other: Exercise Education Other: Sham tDCS Not Applicable

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 primer with tDCS, Treatment as usual (TAU/exercise education) with tDCS, or Exercise primer with 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 fasting blood samples for biomarker analysis will be collected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, blinded, repeated-session, parallel-design study.
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.
Primary Purpose: Treatment
Official Title: Exercise as a Primer for Excitatory Stimulation Study (EXPRESS): A Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : February 2023


Arm Intervention/treatment
Experimental: 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.
Other: tDCS
All study participants randomized to tDCS will receive active tDCS.

Other: Exercise
Participants will exercise at TRI according to an individualized exercise prescription.

Exercise Education and tDCS
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
Other: tDCS
All study participants randomized to tDCS will receive active tDCS.

Other: Exercise Education
Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
Other Name: Treatment as usual

Exercise and Sham tDCS
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Other: Exercise
Participants will exercise at TRI according to an individualized exercise prescription.

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




Primary Outcome Measures :
  1. Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores [ Time Frame: Change over 2 weeks (Midpoint 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.


Secondary Outcome Measures :
  1. Changes in concentration of blood biomarkers of brain plasticity [ Time Frame: Change over 2 weeks (Midpoint to Endpoint) ]
    Biomarkers associated with exercise, tDCS outcomes, angiogenesis and neurogenesis will be obtained from blood work and analyzed using enzyme linked immunosorbent assays.


Other Outcome Measures:
  1. Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI) [ Time Frame: Change over 2 weeks (Midpoint 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.

  2. Change in cognition: n-back reaction time [ Time Frame: Change over 2 weeks (Midpoint to Endpoint) ]
    A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.

  3. Change in cognition: n-back accuracy [ Time Frame: Change over 2 weeks (Midpoint to Endpoint) ]
    A measure of working memory. Number of errors will be recorded. Higher values represent a worse outcome.

  4. Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) [ Time Frame: Change over 2 weeks (Midpoint 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.

  5. Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) [ Time Frame: Change over 2 weeks (Midpoint 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670615


Contacts
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Contact: Celina Liu 416-480-6100 ext 3185 celina.liu@sunnybrook.ca
Contact: Danielle Vieira 416-480-6100 ext 3185 danielle.vieira@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M3H0A7
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03670615    
Other Study ID Numbers: 075-2018
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Alzheimer disease
cognition
transcranial direct current stimulation
exercise
mild cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders