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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03753191
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
28.6
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial direct current stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double-blinded, randomized case-control interventional studydouble-blinded, randomized case-control interventional study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blinded, with randomized case-control
Primary Purpose:
Treatment
Official Title:
The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Oct 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Haemodynamic changes [baseline and 5 minutes after tDCS]

    Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG

  2. Trail Making Test [baseline and 5 minutes after tDCS]

    change in Trail Making Test

  3. Behavior change [baseline and 5 minutes after tDCS]

    Change in the Chinese Multiple Errands Test

  4. N-back task [baseline and 5 minutes after tDCS]

    Change in N-back task

  5. Stop-signal task [baseline and 5 minutes after tDCS]

    Change in Stop-signal task

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hong Kong Polytechnic University Hong Kong Hong Kong

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Frank LAI, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Frank LAI, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT03753191
Other Study ID Numbers:
  • StartUp1.51
First Posted:
Nov 26, 2018
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dementia

Study Results

No Results Posted as of Oct 22, 2020