跳至主要内容
临床试验/NCT04524338
NCT04524338招募中不适用

Longitudinal Study Examining At-Home Transcranial Direct Current Stimulation

Lady Davis Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
General Cognition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

At Home tDCS Users

Experimental

Participants conducting tDCS at home

干预措施: Transcranial Direct Current Stimulation (Device)

结局指标

主要结局

General Cognition

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Roncero

Consultant

Lady Davis Institute

研究点 (1)

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