DementiaNCT03753191
The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia
A study testing transcranial direct current stimulation in people with Dementia and Executive Function, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
To study the effects of transcranial direct current stimulation on executive function in people with mild to moderate dementia Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Executive Function, Transcranial Direct Current Stimulation
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
frank Lai, PhD
Daniel Chan, BSc, daniel430.chan@polyu.edu.hk
About this study
To study the effects of transcranial direct current stimulation on executive function in people with mild to moderate dementia
Read the 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.
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic changes
Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG
Measured: baseline and 5 minutes after tDCS
Trail Making Test
change in Trail Making Test
Measured: baseline and 5 minutes after tDCS
Behavior change
Change in the Chinese Multiple Errands Test
Measured: baseline and 5 minutes after tDCS
N-back task
Change in N-back task
Measured: baseline and 5 minutes after tDCS
Stop-signal task
Change in Stop-signal task
Measured: baseline and 5 minutes after tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Jun 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded, randomized case-control interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Frank LAI, The Hong Kong Polytechnic University
- Investigators
- Frank LAI, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753191
- Sponsor's protocol ID
- StartUp1.51
- Status last verified
- Oct 2020
- First submitted
- 17 Nov 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 11723286Liebetanz 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.
PubMed 12244081Antal 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.
PubMed 15167555Zaehle 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.
PubMed 21211016
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia
- ClinicalTrials.gov ID
- NCT03753191
- Acronym / sponsor ID
- StartUp1.51
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blinded, randomized case-control interventional study
| Arm | Type | Receives |
|---|---|---|
| People with Dementia | Experimental | Device: transcranial direct current stimulationTwenty 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 |
| Health Control | Sham comparator | Device: transcranial direct current stimulationTwenty 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationEach 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. | Device | Health Control, People with Dementia |
Primary outcome
Haemodynamic changes
Time frame: baseline and 5 minutes after tDCS
Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG
Trail Making Test
Time frame: baseline and 5 minutes after tDCS
change in Trail Making Test
Behavior change
Time frame: baseline and 5 minutes after tDCS
Change in the Chinese Multiple Errands Test
N-back task
Time frame: baseline and 5 minutes after tDCS
Change in N-back task
Stop-signal task
Time frame: baseline and 5 minutes after tDCS
Change in Stop-signal task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 11723286Nitsche 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.
- Background: PubMed 12244081Liebetanz 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.
- Results publication: PubMed 15167555Antal 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.
- Results publication: PubMed 21211016Zaehle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank LAI, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Dementia and Executive Function, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank LAI, PhD (2766 6749, frank.hy.lai@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic changes (time frame: baseline and 5 minutes after tDCS). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753191, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.