The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-10-20

Brief Summary

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To study the effects of transcranial direct current stimulation on executive function in people with mild to moderate dementia

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Detailed Description

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Extensive research had shown executive dysfunction in people with dementia (PWD) is associated with functional abnormalities in prefrontal regions such as the right inferior frontal gyrus (Right IFG) or the left dorsal lateral pre-frontal cortex (Left DLPFC) . Clinical studies suggest that tDCS may be a useful therapeutic tool. Post-tDCS improvements have also been shown in visuo-motor coordination of healthy controls and performance in working memory. The aim of this study is to investigate the effect of tDCS stimulation over left DLPFC or right IFG on attention, inhibition and working memory and their neural correlates in people with dementia (PWD) and healthy controls (HC).This study is planned as a double-blinded, randomized case-control interventional study with a duration of 30 months.

Conditions

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Dementia Executive Function Transcranial Direct Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blinded, randomized case-control interventional study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blinded, with randomized case-control

Study Groups

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People with Dementia

Twenty subjects each group will be randomized to receive either anodal tDCS or shame tDCS over the Right iFG or Left DLPFC. A 2mA direct current for active tDCS (current density : .057 mA/cm2) with a 20 mins stimulation period

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

Each subject will undergo one tDCS stimulation session lasting for 20 minutes. A constant current of 2 mA will be applied with a linear fade in, fade out of 10 seconds to prevent electrical transients.

Health Control

Twenty subjects each group will be randomized to receive either anodal tDCS or shame tDCS over the Right iFG or Left DLPFC. After a fade in period of 10s to mimic initial tDCS peripheral skin sensations, the stimulator will be turned off in order to prevent the induction of any neuromodulatory effect.

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

Each subject will undergo one tDCS stimulation session lasting for 20 minutes. A constant current of 2 mA will be applied with a linear fade in, fade out of 10 seconds to prevent electrical transients.

Interventions

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transcranial direct current stimulation

Each subject will undergo one tDCS stimulation session lasting for 20 minutes. A constant current of 2 mA will be applied with a linear fade in, fade out of 10 seconds to prevent electrical transients.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* PWD must be aged at least 65 years or above when informed consent is obtained in the presence of his / her first degree relatives.
* PWD must meet criteria of DSM-V for dementia as well as for historical diagnosis of dementia.
* PWD must have a Chinese MoCA score \> 19 (mild to moderate cognitive deficits) at screening.
* Subjects (both PWD and HC) must be physically healthy, and must be able to understand and be willing to sign the informed consent document

Exclusion Criteria

* Subject with major neurological illness.
* Subject with other diagnosed psychiatric disorders
* Subjects reported with history of substance abuse, which including alcohol, drugs or any medication which is indicative of chronic abuse.
* Failures to comply with the study protocol or to follow the instructions.
* Self-reported with known skin diseases or skin allergy history.
* Self-reported with metallic implants, dentures
* Self-reported with history of claustrophobia. (This is excluded because subject needs to stay in a quiet room with the head-mounted fNIRS and tDCS, which may elicit their feeling of anxiety)

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes