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

The Hong Kong Polytechnic University

Status: Unknown

Conditions: Transcranial Direct Current Stimulation; Dementia; Executive Function

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03753191

StartUp1.51

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

People with Dementia

Experimental group

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

Treatment:

Device: transcranial direct current stimulation

Health Control

Sham Comparator group

Description:

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.

Treatment:

Device: transcranial direct current stimulation