Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
1 other identifier
interventional
42
1 country
1
Brief Summary
There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Sep 2022
Longer than P75 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedAugust 13, 2024
August 1, 2024
3.3 years
August 18, 2022
August 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Naming Training
The primary outcome measure will be change on the naming lists administered, both a trained version and an untrained version. This change will be measured in terms of the number of images correctly named post-training compared to baseline
3 months
Study Arms (3)
4mA Stimulation
EXPERIMENTAL2mA Stimulation
ACTIVE COMPARATORSHAM
SHAM COMPARATORInterventions
Participants will receive mild stimulation or no stimulation along with naming training
Eligibility Criteria
You may qualify if:
- Mild to Moderate AD
- Score between 18 and 25 on the MoCA
- Score on the Cambridge Naming Task during the pre-assessment
You may not qualify if:
- No history of stroke or TBI
- No shunts or metal in the body
- No history of significant heart disease, alcoholism and drug use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baycrestlead
- Alzheimer's Societycollaborator
Study Sites (1)
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Associate
Study Record Dates
First Submitted
August 18, 2022
First Posted
August 22, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
August 13, 2024
Record last verified: 2024-08