ClinicalTrials.gg
RecruitingNCT04524338Updated Aug 13, 2024

Longitudinal Study Examining At-Home tDCS

An interventional study of Transcranial Direct Current Stimulation in Alzheimer Disease, sponsored by Lady Davis Institute. Recruiting at 1 site in Canada. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Lady Davis Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
50 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • Transcranial Direct Current Stimulation
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Lady Davis Institute is the lead sponsor of 46 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Alzheimer's Disease or other form of dementia (e.g., Primary Progressive Aphasia)

Exclusion criteria

Exclusion Criteria:

  • Metal in the head or other factors that would make stimulation unsafe
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    At Home tDCS Users

    Participants conducting tDCS at home

    Device: Transcranial Direct Current Stimulation

Interventions

  • DeviceTranscranial Direct Current Stimulation

    Brain Stimulation Devices attached to scalp

    Also known as: tDCS

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: two years

07

Study locations

1 of 1 sites recruiting
  • Perform Centre
    Montreal, Quebec H4B 1R6, Canada
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04524338
Lead sponsor
Lady Davis Institute
Responsible party
Carlos Roncero (Consultant, Lady Davis Institute) — Principal investigator
First posted
Aug 24, 2020
Start date
Feb 22, 2021
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Aug 13, 2024

Study contacts

Shelley Solomon
Contact
shelley.solomon2@mail.mcgill.ca
514-340-8222 ext. 25129
Jacinta Lesmond
Contact
jlesmond@research.baycrest.org
416-785-2500 ext. 2734
Carlos Roncero, PhD
principal investigator · Baycrest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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