Recruiting

tDCS

Sponsor:

Baycrest

Code:

NCT05509387

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation and naming training

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT05509387

Start date

Sep 1, 2022

Status verified date

Aug, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Mild to Moderate AD
  • Score between 18 and 25 on the MoCA
  • Score on the Cambridge Naming Task during the pre-assessment

Exclusion Criteria:

  • No history of stroke or TBI
  • No shunts or metal in the body
  • No history of significant heart disease, alcoholism and drug use

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 4mA Stimulation

active comparator: 2mA Stimulation

sham comparator: SHAM

Interventions

transcranial direct current stimulation and naming training

Participants will receive mild stimulation or no stimulation along with naming training

Primary outcome measure

  • Naming Training [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Baycrest Health Sciences

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

More Information

Sponsor

Baycrest

Last update posted

Aug 13, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baycrest on 2024-08-13.