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

Sponsor

Baycrest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05509387

Collaborator

Alzheimer's Society (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Device: transcranial direct current stimulation and naming training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4mA Stimulation	Device: transcranial direct current stimulation and naming training Participants will receive mild stimulation or no stimulation along with naming training
Active Comparator: 2mA Stimulation	Device: transcranial direct current stimulation and naming training Participants will receive mild stimulation or no stimulation along with naming training
Sham Comparator: SHAM	Device: transcranial direct current stimulation and naming training Participants will receive mild stimulation or no stimulation along with naming training

Arm

Intervention/Treatment

Experimental: 4mA Stimulation

Device: transcranial direct current stimulation and naming training

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

Active Comparator: 2mA Stimulation

Device: transcranial direct current stimulation and naming training

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

Sham Comparator: SHAM

Device: transcranial direct current stimulation and naming training

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

Outcome Measures

Primary Outcome Measures

Naming Training [3 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baycrest Health Sciences	Toronto	Ontario	Canada	M6A 2E1

Sponsors and Collaborators

Baycrest
Alzheimer's Society

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Tyler Roncero, Scientific Associate, Baycrest

ClinicalTrials.gov Identifier:

NCT05509387

Other Study ID Numbers:

#22-19

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Aug 23, 2022