Longitudinal Study Examining At-Home tDCS
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Transcranial Direct Current Stimulation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Alzheimer's Disease or other form of dementia (e.g., Primary Progressive Aphasia)
Exclusion Criteria:
- Metal in the head or other factors that would make stimulation unsafe
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
At Home tDCS Users
Arm Description
Participants conducting tDCS at home
Outcomes
Primary Outcome Measures
General Cognition
Improved General Cognition as defined by scores on the Montreal Cognitive Assessment. Test has scores from 0-30, where higher scores reflect better cognition. In this study, an increased score would reflect an improvement in general cognition, which we would interpret as associated with the application of transcranial direct current stimulation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04524338
Brief Title
Longitudinal Study Examining At-Home tDCS
Official Title
Longitudinal Study Examining At-Home Transcranial Direct Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2020 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants with dementia have reported improvements after receiving tDCS in a study at our lab. Although we make an effort to enroll such participants in further tDCS research studies, some participants are ineligible for further studies or simply unwilling to continue being a research participant. These same individuals, however, are interested in purchasing their own tDCS machine and have approached us for advice on how to purchase their own machine. Because these devices are commercially available, there is nothing theoretically stopping these participants from purchasing their own machine. Therefore, we have chosen to carry out a longitudinal study that will allow us to serve as an advisory role for participants who have decided to continue administering tDCS at home. We will recommend the tDCS related items that should be purchased, and train participants on how to properly administer tDCS. Monthly reports will also be collected, which will allow us to monitor the person's condition. We plan to monitor participants for at least two years. From these reports, we will be able determine to what extent tDCS is beneficial when done at home as a treatment for dementia symptoms.
Detailed Description
In the past decade, several studies have noted that the application of transcranial direct current stimulation (tDCS) when applied to the scalp of a person with dementia, as they completed a training task in a particular domain, can lead to improved performance on that task (liu, Rau, Gallagher, Rajji, Lanctot, & Hermann, 2017). In our own lab, we have also seen improvements in response to the application of TdCS. For example, we found that applying transcranial direct current stimulation (tDCS) to people with dementia led to an improvement in naming ability (Roncero, Kniefel, Service, Thiel, Probst, & Chertkow, 2017). Recently, we have initiated additional studies in domains such as executive function and memory. These studies remain in progress, but participants have again shown improvement, and the improvement is noted by the families. Some of the participants who completed a tDCS study in our lab are so impressed by the results that they have approached us about the purchase of their own tDCS machine. Some of these participants have even tried medication in the past and report tDCS is more effective. Because tDCS machines are commercially available, these individuals could in theory go about buying their own machines at their own initiative; however, participants would prefer our assistance obtaining a machine and be trained on how to administer tDCS at home.
Proposed Study We will assist participants obtain their own tDCS machine, we have decided to do so in the form of a longitudinal study. More specifically, we plan to assist participants obtain their own machine and train them on the administration of tDCS, but will also collect longitudinal data from them. We will obtain monthly reports that will allow us to monitor whether stimulation remains effective and the general condition of the participant for at least two years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Transcranial Direct Current Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
At Home tDCS Users
Arm Type
Experimental
Arm Description
Participants conducting tDCS at home
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Brain Stimulation Devices attached to scalp
Primary Outcome Measure Information:
Title
General Cognition
Description
Improved General Cognition as defined by scores on the Montreal Cognitive Assessment. Test has scores from 0-30, where higher scores reflect better cognition. In this study, an increased score would reflect an improvement in general cognition, which we would interpret as associated with the application of transcranial direct current stimulation
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Alzheimer's Disease or other form of dementia (e.g., Primary Progressive Aphasia)
Exclusion Criteria:
Metal in the head or other factors that would make stimulation unsafe
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelley Solomon
Phone
514-340-8222
Ext
25129
Email
shelley.solomon2@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jacinta Lesmond
Phone
416-785-2500
Ext
2734
Email
jlesmond@research.baycrest.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Roncero, PhD
Organizational Affiliation
Baycrest
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Longitudinal Study Examining At-Home tDCS
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