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Longitudinal Study Examining At-Home tDCS

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ClinicalTrials.gov Identifier: NCT04524338
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Roncero, Lady Davis Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: Transcranial Direct Current Stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Longitudinal Study Examining At-Home Transcranial Direct Current Stimulation
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: At Home tDCS Users
Participants conducting tDCS at home
 Device: Transcranial Direct Current Stimulation
Brain Stimulation Devices attached to scalp
Other Name: tDCS


Outcome Measures
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Primary Outcome Measures :
  1. General Cognition [ Time Frame: two years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524338


Contacts
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Contact: Shelley Solomon 514-340-8222 ext 25129 shelley.solomon2@mail.mcgill.ca
Contact: Jacinta Lesmond 416-785-2500 ext 2734 jlesmond@research.baycrest.org

Sponsors and Collaborators
Lady Davis Institute
Investigators
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Principal Investigator: Carlos Roncero, PhD Baycrest
More Information
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Responsible Party: Carlos Roncero, Consultant, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT04524338    
Other Study ID Numbers: #2020-1885
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Roncero, Lady Davis Institute:
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders