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

NCT03753191 | Unknown

• 1 other identifier: StartUp1.51
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dementia; Executive Function; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

People with Dementia

EXPERIMENTAL

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

Health Control

SHAM COMPARATOR

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

Interventions

transcranial direct current stimulation DEVICE

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.

Health Control; People with Dementia

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

• 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.

  PMID: 11723286 BACKGROUND

• 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.

  PMID: 12244081 BACKGROUND

• 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.

  PMID: 15167555 RESULT

• 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.

  PMID: 21211016 RESULT

MeSH Terms

Conditions

Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Frank LAI, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank LAI, PhD

CONTACT

2766 6749; frank.hy.lai@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded, with randomized case-control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: double-blinded, randomized case-control interventional study

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 26, 2018
• Study Start: June 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: October 20, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)