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

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

Study Overview

• Status: Unknown
• Conditions: Dementia; Executive Function; Transcranial Direct Current Stimulation
• Intervention / Treatment: Device: transcranial direct current stimulation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: frank Lai, PhD
    • Contact: Daniel Chan, BSc; Email: daniel430.chan@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.
Sham Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Frank LAI, PhD, Assistant Professor

Publications and helpful links

General Publications

• Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
• Liebetanz D, Nitsche MA, Tergau F, Paulus W. Pharmacological approach to the mechanisms of transcranial DC-stimulation-induced after-effects of human motor cortex excitability. Brain. 2002 Oct;125(Pt 10):2238-47. doi: 10.1093/brain/awf238.
• Antal A, Varga ET, Kincses TZ, Nitsche MA, Paulus W. Oscillatory brain activity and transcranial direct current stimulation in humans. Neuroreport. 2004 Jun 7;15(8):1307-10. doi: 10.1097/01.wnr.0000127460.08361.84.
• Zaehle T, Sandmann P, Thorne JD, Jancke L, Herrmann CS. Transcranial direct current stimulation of the prefrontal cortex modulates working memory performance: combined behavioural and electrophysiological evidence. BMC Neurosci. 2011 Jan 6;12:2. doi: 10.1186/1471-2202-12-2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): October 20, 2021

Study Registration Dates

• First Submitted: November 17, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: StartUp1.51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No