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

Primary Purpose

Dementia, Executive Function, Transcranial Direct Current Stimulation

Status

Unknown status

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

People with Dementia

Health Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Haemodynamic changes

Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG

Trail Making Test

change in Trail Making Test

Behavior change

Change in the Chinese Multiple Errands Test

N-back task

Change in N-back task

Stop-signal task

Change in Stop-signal task

Secondary Outcome Measures

Full Information

NCT ID

NCT03753191

First Posted

November 17, 2018

Last Updated

October 20, 2020

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT03753191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

October 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia, Executive Function, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

double-blinded, randomized case-control interventional study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double-blinded, with randomized case-control

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

People with Dementia

Arm Type

Experimental

Arm Description

Arm Title

Health Control

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Haemodynamic changes

Description

Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG

Time Frame