search
Back to results

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
Lady Davis Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Transcranial Direct Current Stimulation

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 20, 2020
    Last Updated
    August 24, 2020
    Sponsor
    Lady Davis Institute
    search

    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

    Learn more about this trial

    Longitudinal Study Examining At-Home tDCS

    We'll reach out to this number within 24 hrs