Clinical trial NCT03753191: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Executive Function
Transcranial Direct Current Stimulation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded, randomized case-control interventional study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Haemodynamic changes
timeFrame: baseline and 5 minutes after tDCS
measure: Trail Making Test
timeFrame: baseline and 5 minutes after tDCS
measure: Behavior change
timeFrame: baseline and 5 minutes after tDCS
measure: N-back task
timeFrame: baseline and 5 minutes after tDCS
measure: Stop-signal task
timeFrame: baseline and 5 minutes after tDCS
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: Assistant Professor
name: Frank LAI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1212/wnl.57.10.1899.
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. doi: 10.1093/brain/awf238.
citation: 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.
citation: 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.