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

Not Applicable

• Conditions: Dementia; Transcranial Direct Current Stimulation; Executive Function
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT03753191
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Study First Submitted: 2018-11-17
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Study Start: 2019-06-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2020-12-30
• Study Completion: 2021-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
People with Dementia	transcranial direct current stimulation	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
Health Control	transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Trail Making Test	baseline and 5 minutes after tDCS	change in Trail Making Test
Haemodynamic changes	baseline and 5 minutes after tDCS	Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG
Behavior change	baseline and 5 minutes after tDCS	Change in the Chinese Multiple Errands Test
N-back task	baseline and 5 minutes after tDCS	Change in N-back task
Stop-signal task	baseline and 5 minutes after tDCS	Change in Stop-signal task

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong