NCT04524338

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
5mo left

Started Feb 2021

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Feb 2021Oct 2026

First Submitted

Initial submission to the registry

August 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

5.7 years

First QC Date

August 20, 2020

Last Update Submit

August 9, 2024

Conditions

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

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

    two years

Study Arms (1)

At Home tDCS Users

EXPERIMENTAL

Participants conducting tDCS at home

Device: Transcranial Direct Current Stimulation

Interventions

Brain Stimulation Devices attached to scalp

Also known as: tDCS
At Home tDCS Users

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Perform Centre

Montreal, Quebec, H4B 1R6, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Carlos Roncero, PhD

    Baycrest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 24, 2020

Study Start

February 22, 2021

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations