Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
transcranial direct current stimulation and naming training
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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
Sites / Locations
- Baycrest Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
4mA Stimulation
2mA Stimulation
SHAM
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05509387
First Posted
August 18, 2022
Last Updated
August 19, 2022
Sponsor
Baycrest
Collaborators
Alzheimer's Society
1. Study Identification
Unique Protocol Identification Number
NCT05509387
Brief Title
Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
Official Title
Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
Alzheimer's Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4mA Stimulation
Arm Type
Experimental
Arm Title
2mA Stimulation
Arm Type
Active Comparator
Arm Title
SHAM
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation and naming training
Intervention Description
Participants will receive mild stimulation or no stimulation along with naming training
Primary Outcome Measure Information:
Title
Naming Training
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Roncero, PhD
Email
troncero@research.baycrest.org
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Roncero, PhD
Phone
416-785-2500
Ext
2522
Email
troncero@research.baycrest.org
First Name & Middle Initial & Last Name & Degree
Yashna Kochar, H. BSc
Phone
416-785-2500
Ext
2522
Email
ykochar@research.baycrest.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
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