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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753191
• Other study ID #: StartUp1.51
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 20, 2021

Study information

• Verified date: October 2020
• Source: The Hong Kong Polytechnic University
• Contact: Frank LAI, PhD
• Phone: 2766 6749
• Email: frank.hy.lai[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 20, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dementia
• Executive Function
• Transcranial Direct Current Stimulation

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

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. — View Citation

Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. — View Citation

Zaehle T, Sandmann P, Thorne JD, Jäncke 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Trail Making Test	change in Trail Making Test	baseline and 5 minutes after tDCS
Primary	Behavior change	Change in the Chinese Multiple Errands Test	baseline and 5 minutes after tDCS
Primary	N-back task	Change in N-back task	baseline and 5 minutes after tDCS
Primary	Stop-signal task	Change in Stop-signal task	baseline and 5 minutes after tDCS