Mild Cognitive ImpairmentNCT05584748
Effects of tDCS on Cognition in MCI: A RCT
A study testing transcranial direct current stimulation in people with Mild Cognitive Impairment, run by Tung Wah College.
Trial summary
MCI is considered an intermediate stage between normal cognitive aging and dementia. As such, improving cognitive functions of people with MCI may delay dementia onset. In recent years, tDCS, which regulates brain activity by increasing or decreasing brain tissue excitability, has become a commonly used brain… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- 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
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to May 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inexperienced with tDCS
- normal or corrected-to-normal vision
- right-handed
- independent in activities of daily living
- no history of seizures, head injuries, migraine, epilepsy or other psychiatric or neurological conditions
Who cannot join
- taking medication or supplements known to affect cognition (such as Ginkgo)
- exhibiting symptoms of emotional disorders
- having a history of cerebrovascular surgery
- with a metal plate in their skull
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Cognition in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
MCI is considered an intermediate stage between normal cognitive aging and dementia. As such, improving cognitive functions of people with MCI may delay dementia onset. In recent years, tDCS, which regulates brain activity by increasing or decreasing brain tissue excitability, has become a commonly used brain stimulation method. Accumulating evidence indicates the promising effects of cognitive enhancement after tDCS over the frontal scalp regions in people with MCI (PwMCI). However, previous studies were limited by including only a self-report measure, focused on memory performance, not assessing long-term effect, and not reporting their results in follow-up. In addition, knowledge of the precise physiological consequences of tDCS on the brain tissue and related neural mechanisms in PwMCI remains rudimentary. The objectives of the proposed study, which will target PwMCI, are to investigate the effects of tDCS at the left dorsolateral prefrontal cortex on the cognitive performance and to explore the modulation of neural mechanisms associated with the use of tDCS. Forty-eight MCI participants aged over 60 years will be recruited. All participants will be assessed by Hong Kong version of Montreal Cognitive Test. Participants that meet selection criteria will be invited to the experiment. Participants will be assigned to experimental or control groups randomly. The experiment will consist of pre- and post-assessments and a 1-month follow-up assessment. Between pre- and post-assessments, participants will receive 8 sessions (2x/week for 4 weeks) of tDCS treatment (either real or sham, 20 min per session). Outcome measures include digit span test, colour trail test, verbal fluency test, Chinese version of the Verbal Learning Test , and Hong Kong version of Montreal Cognitive Assessment. Participants will also complete a computer memory task at each assessment point (performance in this task is also used as an outcome measure) and will have their brain wave recorded while completing the task. The task will require them to study and memorise Chinese characters, followed by a recognition memory test. In the study phase, participants will be required to view Chinese characters and judge whether the characters are of the animal category. In the recognition phase, participants will decide whether the characters have been seen before.
Read the detailed description
Randomization and blinding Due to limited available resources and the time required to collect the data, the investigators plan to implement the experiment in 4 batches, each separated by approximately two months. Each batch will include 12 participants from the same recruiting site. Six of them will be assigned to the anodal group and the other six to the sham group, using the block randomization method provided by http://www.randomization.com. The online software generates group allocation by knowing the number of participants per block (6) and number of blocks (2). Only the principal investigator will know the group assignments. Neither the participants nor the assessors will be given the information regarding the group assignments. Each participant will be given a registration number by the Principal Investigator. The tDCS device can be set to anodal or sham status. The PI will set up the tDCS device (anodal or sham) according to the participant's registration number and group through the device's administration menu. The research associate will select the stimulation protocol by inputting the participant's registration number on the device and be blinded to the participant's group assignment when performing tDCS stimulation and other assessments.
Sample size calculation The investigators used G*Power software to estimate the number of participants required to conduct repeated measure analyses of variance (within-between interactions) using the following parameters: correlation among repeated measures = 0.5, alpha = 0.05, number of groups = 2, power = 0.9 and number of measurements = 3 (assuming the correlation between repeated measures = 0.9). Effect size f is conservatively assumed to be 0.25. Based on previous experience using tDCS on participants with dementia and previous relevant studies, the investigators assumed a retention rate of 75%. Thus, the required sample size would be 48.
Procedure This proposed investigation will use a sham-controlled, randomized controlled trial. Participants will be randomly assigned to the anodal or sham groups (in 1:1 ratio). The stimulation method (anodal/sham) will be designated as the between-subject factor (independent variable). The potential participants will be screened and those who meet the selection criteria will be invited to participate in the study. Participants will attend a baseline assessment session in which the collection of demographic information, neurocognitive assessment scores, and a computer task with EEG recorded will occur, followed by 8 sessions of anodal tDCS completed twice a week for 4 weeks. Multi-session tDCS studies usually have a varied intervention schedule from 1 to 5 sessions per week for 1 to 5 weeks. The investigators have opted for this schedule to balance the time spent on intervention with its potential effectiveness, and to encourage compliance. After the intervention, participants will receive post- and 1-month follow-up assessments which will be the same as the baseline assessment.
EEG data acquisition EEGs will be recorded from 64 Ag/AgCl electrodes (BioSemi Active Two) located on the standard scalp sites of the 10/20 system. Four electrodes will be used to monitor eye blinks and movements. Two other electrodes will be placed in the mastoids for the EEG signal to be re-referenced off-line. Scalp EEG will be recorded from F3. Curry 9 software (Neuroscan Compumedics, U.S.A), or newer, will be used for the EEG signal processing. The EEGs will be sampled at 1024 Hz, with a low-pass filter of -200 μV. Digital band-pass filtering from 0.1 Hz to 30 Hz will be applied off-line. The continuous EEG signals will be segmented into epochs, from 200 ms before the stimulus to 1500 ms after the stimulus onset, and then the baseline will be corrected to the pre-stimulus interval. The epochs with amplitude ± 75 μV will be omitted from averaging. The averaged ERPs will be computed for each participant by classifying the study epochs that are correctly identified subsequently or missed during the recognition phase. Using the Curry 9 software, these averaged ERP files will then be transformed into text files with voltage (μV) and temporal information (ms) that can be read by Microsoft Excel software. After further rearrangement and processing in Excel, the data will be transferred to SPSS software for statistical analysis.
- Conditions
- Mild Cognitive Impairment
- Being tested
- transcranial direct current stimulation
- Keywords
- tDCS, ERP/EEG, Cognition, Dorsolateral prefrontal cortex
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
tDCS is planned to be administered via electrodes positioned over the left dlPFC (anodal/sham electrode) and the left supraorbital area (reference electrode).
| Study group | Role | What they receive |
|---|---|---|
| Simulation group | Experimental | During anodal stimulation, the participants will receive 1.5 mA of constant current over the site for 20 min, with a 15-second ramp up and scale down at the beginning and the end of the procedure. Receives: Device: transcranial direct current stimulation |
| Sham group | Sham comparator | In the sham stimulation condition, the current will only be administered during the first 30 seconds and last 30 seconds of the 20-minute window. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit span test (Wechsler & De Lemos, 1981)
Participants are presented with a random series of digits, and are asked to repeat them in the order presented.
Measured: 2 minutes
Colour Trail Test (CTT) (D' Elia et al., 1996)
CTT1: Must be administered first and requires the respondent to connect circles in an ascending numbered sequence (1-25).
CTT2: Must follow the CTT1 and requires the respondent to connect numbers in an ascending sequence while alternating between pink and yellow colors.
Measured: 8 minutes
verbal fluency test (Lezak et al., 2004)
Participants produce as many words as possible from a category in 60 seconds.
Measured: 3 minutes
Chinese version of the Verbal Learning Test (Chang et al., 2010)
Participants repeat 9 Chinese words after they are presented.
Measured: 10 minutes
Hong Kong version of Montreal Cognitive Assessment (Yeung et al., 2014)
A screening tool for MCI
Measured: 15 minutes
Computerized memory task
During the study phase of the memory task, the participants will view the Chinese words on a computer screen and decide whether they are from the animal category. After finishing the study/encoding phase, the participants will perform the recognition/test task. During this task, the participants will view characters and judge whether they had seen them previously in the study phase.
Measured: 40 minutes
Event-related potential
Electroencephalograms are recorded while completing the computerized memory task
Measured: 40 minutes
Secondary outcomes (1)
Geriatric Depression Scale (Chiu et al., 1994)
This is a screening test for major depression. There are 15 items. Cut off score is 7/8.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study startJun 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chih Chien KUO, PhD, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584748
- Sponsor's protocol ID
- UGC/FDS17/M06/22
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kuo MC, Liu KP, Ting KH, Chan CC. Differentiation of perceptual and semantic subsequent memory effects using an orthographic paradigm. Brain Res. 2012 Nov 27;1486:82-91. doi: 10.1016/j.brainres.2012.10.005. Epub 2012 Oct 10.
PubMed 23063888Kuo MC, Liu KP, Ting KH, Chan CC. Age-related effects on perceptual and semantic encoding in memory. Neuroscience. 2014 Mar 7;261:95-106. doi: 10.1016/j.neuroscience.2013.12.036. Epub 2013 Dec 25.
PubMed 24374080Meinzer M, Lindenberg R, Antonenko D, Flaisch T, Floel A. Anodal transcranial direct current stimulation temporarily reverses age-associated cognitive decline and functional brain activity changes. J Neurosci. 2013 Jul 24;33(30):12470-8. doi: 10.1523/JNEUROSCI.5743-12.2013.
PubMed 23884951Meinzer M, Lindenberg R, Phan MT, Ulm L, Volk C, Floel A. Transcranial direct current stimulation in mild cognitive impairment: Behavioral effects and neural mechanisms. Alzheimers Dement. 2015 Sep;11(9):1032-40. doi: 10.1016/j.jalz.2014.07.159. Epub 2014 Nov 20.
PubMed 25449530Ownby RL, Acevedo A. A pilot study of cognitive training with and without transcranial direct current stimulation to improve cognition in older persons with HIV-related cognitive impairment. Neuropsychiatr Dis Treat. 2016 Oct 25;12:2745-2754. doi: 10.2147/NDT.S120282. eCollection 2016.
PubMed 27822047Fileccia E, Di Stasi V, Poda R, Rizzo G, Stanzani-Maserati M, Oppi F, Avoni P, Capellari S, Liguori R. Effects on cognition of 20-day anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex in patients affected by mild cognitive impairment: a case-control study. Neurol Sci. 2019 Sep;40(9):1865-1872. doi: 10.1007/s10072-019-03903-6. Epub 2019 May 7.
PubMed 31062189Gomes MA, Akiba HT, Gomes JS, Trevizol AP, de Lacerda ALT, Dias AM. Transcranial direct current stimulation (tDCS) in elderly with mild cognitive impairment: A pilot study. Dement Neuropsychol. 2019 Apr-Jun;13(2):187-195. doi: 10.1590/1980-57642018dn13-020007.
PubMed 31285793Kuo MCC, Tan GHD, Hu X, Yau MYC, Yip CK. Effects of transcranial direct current stimulation (tDCS) on cognition in older adults with mild cognitive impairment: a study protocol for a randomized controlled trial. Trials. 2026 Apr 22;27(1):328. doi: 10.1186/s13063-026-09688-2.
PubMed 42021325
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Cognition in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05584748
- Acronym / sponsor ID
- UGC/FDS17/M06/22
- Conditions
- Mild Cognitive Impairment
- Keywords
- tDCS, ERP/EEG, Cognition, Dorsolateral prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Oct 2022 (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.
MCI is considered an intermediate stage between normal cognitive aging and dementia. As such, improving cognitive functions of people with MCI may delay dementia onset. In recent years, tDCS, which regulates brain activity by increasing or decreasing brain tissue excitability, has become a commonly used brain stimulation method. Accumulating evidence indicates the promising effects of cognitive enhancement after tDCS over the frontal scalp regions in people with MCI (PwMCI). However, previous studies were limited by including only a self-report measure, focused on memory performance, not assessing long-term effect, and not reporting their results in follow-up. In addition, knowledge of the precise physiological consequences of tDCS on the brain tissue and related neural mechanisms in PwMCI remains rudimentary. The objectives of the proposed study, which will target PwMCI, are to investigate the effects of tDCS at the left dorsolateral prefrontal cortex on the cognitive performance and to explore the modulation of neural mechanisms associated with the use of tDCS. Forty-eight MCI participants aged over 60 years will be recruited. All participants will be assessed by Hong Kong version of Montreal Cognitive Test. Participants that meet selection criteria will be invited to the experiment. Participants will be assigned to experimental or control groups randomly. The experiment will consist of pre- and post-assessments and a 1-month follow-up assessment. Between pre- and post-assessments, participants will receive 8 sessions (2x/week for 4 weeks) of tDCS treatment (either real or sham, 20 min per session). Outcome measures include digit span test, colour trail test, verbal fluency test, Chinese version of the Verbal Learning Test , and Hong Kong version of Montreal Cognitive Assessment. Participants will also complete a computer memory task at each assessment point (performance in this task is also used as an outcome measure) and will have their brain wave recorded while completing the task. The task will require them to study and memorise Chinese characters, followed by a recognition memory test. In the study phase, participants will be required to view Chinese characters and judge whether the characters are of the animal category. In the recognition phase, participants will decide whether the characters have been seen before.
Detailed description
Randomization and blinding Due to limited available resources and the time required to collect the data, the investigators plan to implement the experiment in 4 batches, each separated by approximately two months. Each batch will include 12 participants from the same recruiting site. Six of them will be assigned to the anodal group and the other six to the sham group, using the block randomization method provided by http://www.randomization.com. The online software generates group allocation by knowing the number of participants per block (6) and number of blocks (2). Only the principal investigator will know the group assignments. Neither the participants nor the assessors will be given the information regarding the group assignments. Each participant will be given a registration number by the Principal Investigator. The tDCS device can be set to anodal or sham status. The PI will set up the tDCS device (anodal or sham) according to the participant's registration number and group through the device's administration menu. The research associate will select the stimulation protocol by inputting the participant's registration number on the device and be blinded to the participant's group assignment when performing tDCS stimulation and other assessments.
Sample size calculation The investigators used G*Power software to estimate the number of participants required to conduct repeated measure analyses of variance (within-between interactions) using the following parameters: correlation among repeated measures = 0.5, alpha = 0.05, number of groups = 2, power = 0.9 and number of measurements = 3 (assuming the correlation between repeated measures = 0.9). Effect size f is conservatively assumed to be 0.25. Based on previous experience using tDCS on participants with dementia and previous relevant studies, the investigators assumed a retention rate of 75%. Thus, the required sample size would be 48.
Procedure This proposed investigation will use a sham-controlled, randomized controlled trial. Participants will be randomly assigned to the anodal or sham groups (in 1:1 ratio). The stimulation method (anodal/sham) will be designated as the between-subject factor (independent variable). The potential participants will be screened and those who meet the selection criteria will be invited to participate in the study. Participants will attend a baseline assessment session in which the collection of demographic information, neurocognitive assessment scores, and a computer task with EEG recorded will occur, followed by 8 sessions of anodal tDCS completed twice a week for 4 weeks. Multi-session tDCS studies usually have a varied intervention schedule from 1 to 5 sessions per week for 1 to 5 weeks. The investigators have opted for this schedule to balance the time spent on intervention with its potential effectiveness, and to encourage compliance. After the intervention, participants will receive post- and 1-month follow-up assessments which will be the same as the baseline assessment.
EEG data acquisition EEGs will be recorded from 64 Ag/AgCl electrodes (BioSemi Active Two) located on the standard scalp sites of the 10/20 system. Four electrodes will be used to monitor eye blinks and movements. Two other electrodes will be placed in the mastoids for the EEG signal to be re-referenced off-line. Scalp EEG will be recorded from F3. Curry 9 software (Neuroscan Compumedics, U.S.A), or newer, will be used for the EEG signal processing. The EEGs will be sampled at 1024 Hz, with a low-pass filter of -200 μV. Digital band-pass filtering from 0.1 Hz to 30 Hz will be applied off-line. The continuous EEG signals will be segmented into epochs, from 200 ms before the stimulus to 1500 ms after the stimulus onset, and then the baseline will be corrected to the pre-stimulus interval. The epochs with amplitude ± 75 μV will be omitted from averaging. The averaged ERPs will be computed for each participant by classifying the study epochs that are correctly identified subsequently or missed during the recognition phase. Using the Curry 9 software, these averaged ERP files will then be transformed into text files with voltage (μV) and temporal information (ms) that can be read by Microsoft Excel software. After further rearrangement and processing in Excel, the data will be transferred to SPSS software for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation group | Experimental | Device: transcranial direct current stimulationDuring anodal stimulation, the participants will receive 1.5 mA of constant current over the site for 20 min, with a 15-second ramp up and scale down at the beginning and the end of the procedure. |
| Sham group | Sham comparator | Device: transcranial direct current stimulationIn the sham stimulation condition, the current will only be administered during the first 30 seconds and last 30 seconds of the 20-minute window. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- inexperienced with tDCS
- normal or corrected-to-normal vision
- right-handed
- independent in activities of daily living
- no history of seizures, head injuries, migraine, epilepsy or other psychiatric or neurological conditions
Key exclusion criteria (4 listed)
- taking medication or supplements known to affect cognition (such as Ginkgo)
- exhibiting symptoms of emotional disorders
- having a history of cerebrovascular surgery
- with a metal plate in their skull
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 stimulationtDCS is planned to be administered via electrodes positioned over the left dlPFC (anodal/sham electrode) and the left supraorbital area (reference electrode). | Device | Sham group, Simulation group |
Primary outcome
Digit span test (Wechsler & De Lemos, 1981)
Time frame: 2 minutes
Participants are presented with a random series of digits, and are asked to repeat them in the order presented.
Colour Trail Test (CTT) (D' Elia et al., 1996)
Time frame: 8 minutes
CTT1: Must be administered first and requires the respondent to connect circles in an ascending numbered sequence (1-25). CTT2: Must follow the CTT1 and requires the respondent to connect numbers in an ascending sequence while alternating between pink and yellow colors.
verbal fluency test (Lezak et al., 2004)
Time frame: 3 minutes
Participants produce as many words as possible from a category in 60 seconds.
Chinese version of the Verbal Learning Test (Chang et al., 2010)
Time frame: 10 minutes
Participants repeat 9 Chinese words after they are presented.
Hong Kong version of Montreal Cognitive Assessment (Yeung et al., 2014)
Time frame: 15 minutes
A screening tool for MCI
Computerized memory task
Time frame: 40 minutes
During the study phase of the memory task, the participants will view the Chinese words on a computer screen and decide whether they are from the animal category. After finishing the study/encoding phase, the participants will perform the recognition/test task. During this task, the participants will view characters and judge whether they had seen them previously in the study phase.
Event-related potential
Time frame: 40 minutes
Electroencephalograms are recorded while completing the computerized memory task
1 secondary outcome
Geriatric Depression Scale (Chiu et al., 1994)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 23063888Kuo MC, Liu KP, Ting KH, Chan CC. Differentiation of perceptual and semantic subsequent memory effects using an orthographic paradigm. Brain Res. 2012 Nov 27;1486:82-91. doi: 10.1016/j.brainres.2012.10.005. Epub 2012 Oct 10.
- Background: PubMed 24374080Kuo MC, Liu KP, Ting KH, Chan CC. Age-related effects on perceptual and semantic encoding in memory. Neuroscience. 2014 Mar 7;261:95-106. doi: 10.1016/j.neuroscience.2013.12.036. Epub 2013 Dec 25.
- Background: PubMed 23884951Meinzer M, Lindenberg R, Antonenko D, Flaisch T, Floel A. Anodal transcranial direct current stimulation temporarily reverses age-associated cognitive decline and functional brain activity changes. J Neurosci. 2013 Jul 24;33(30):12470-8. doi: 10.1523/JNEUROSCI.5743-12.2013.
- Background: PubMed 25449530Meinzer M, Lindenberg R, Phan MT, Ulm L, Volk C, Floel A. Transcranial direct current stimulation in mild cognitive impairment: Behavioral effects and neural mechanisms. Alzheimers Dement. 2015 Sep;11(9):1032-40. doi: 10.1016/j.jalz.2014.07.159. Epub 2014 Nov 20.
- Background: PubMed 27822047Ownby RL, Acevedo A. A pilot study of cognitive training with and without transcranial direct current stimulation to improve cognition in older persons with HIV-related cognitive impairment. Neuropsychiatr Dis Treat. 2016 Oct 25;12:2745-2754. doi: 10.2147/NDT.S120282. eCollection 2016.
- Background: PubMed 31062189Fileccia E, Di Stasi V, Poda R, Rizzo G, Stanzani-Maserati M, Oppi F, Avoni P, Capellari S, Liguori R. Effects on cognition of 20-day anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex in patients affected by mild cognitive impairment: a case-control study. Neurol Sci. 2019 Sep;40(9):1865-1872. doi: 10.1007/s10072-019-03903-6. Epub 2019 May 7.
- Background: PubMed 31285793Gomes MA, Akiba HT, Gomes JS, Trevizol AP, de Lacerda ALT, Dias AM. Transcranial direct current stimulation (tDCS) in elderly with mild cognitive impairment: A pilot study. Dement Neuropsychol. 2019 Apr-Jun;13(2):187-195. doi: 10.1590/1980-57642018dn13-020007.
- Derived from this study: PubMed 42021325Kuo MCC, Tan GHD, Hu X, Yau MYC, Yip CK. Effects of transcranial direct current stimulation (tDCS) on cognition in older adults with mild cognitive impairment: a study protocol for a randomized controlled trial. Trials. 2026 Apr 22;27(1):328. doi: 10.1186/s13063-026-09688-2.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Mild Cognitive Impairment, run by Tung Wah College.
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 5 inclusion and 4 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Michael Kuo, PhD (+85234686656, michaelkuo@twc.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit span test (Wechsler & De Lemos, 1981) (time frame: 2 minutes). The study lists 7 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 NCT05584748, which also lists 8 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 18 Oct 2022.