Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease

NCT ID: NCT05509387

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

4mA Stimulation

Group Type: EXPERIMENTAL

transcranial direct current stimulation and naming training

Intervention Type: DEVICE

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

2mA Stimulation

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation and naming training

Intervention Type: DEVICE

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

SHAM

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation and naming training

Intervention Type: DEVICE

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

Interventions

transcranial direct current stimulation and naming training

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer's Society

OTHER

Sponsor Role: collaborator

Baycrest

OTHER

Sponsor Role: lead

Responsible Party

Tyler Roncero

Scientific Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baycrest Health Sciences

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Carlos Roncero, PhD

Role: CONTACT

troncero@research.baycrest.org

Facility Contacts

Carlos Roncero, PhD

Role: primary

troncero@research.baycrest.org

416-785-2500 ext. 2522

Yashna Kochar, H. BSc

Role: backup

ykochar@research.baycrest.org

416-785-2500 ext. 2522

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

#22-19

Identifier Type: -

Identifier Source: org_study_id