Subjective Cognitive Complaints (SCCs)NCT07433738
Personalized Assessment of High-definition Slow-oscillatory Transcranial Direct Current Stimulation (So-tDCS) in Older Adults With Subjective Cognitive and Sleep Complaints
A study testing so-tDCS in people with Subjective Cognitive Complaints (SCCs) and Sleep, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Subjective cognitive decline (SCD) is considered to be the early risk stage of dementia. Untreated SCD comorbid with sleep disturbances may accelerate the progression of neurodegeneration (β-amyloid and tau) and lead to cognitive deficits. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Subjective Cognitive Complaints (SCCs), Sleep
- What is being tested?
- so-tDCS
- 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 May 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese, right-handed, aged from 60 to 85 years.
- Normal global cognition defined as a total score of the Montreal Cognitive Assessment Hong Kong version (HK MoCA) > 26.
- Subjective cognitive decline (SCD) is evaluated by a 10-item questionnaire that covers subjective cognitive complaints (SCC) in the core cognitive domains.
- Sleep disturbances or poor sleep quality is assessed and defined with a total score of the Pittsburgh Sleep Quality Index (PSQI) greater than 5.
Who cannot join
- Previous diagnosis of age-related neurodegenerative diseases, such as Alzheimer's disease, Parkinson disease.
- History of neurological diseases including brain tumor, and stroke.
- History of psychiatric disorders including schizophrenia and depression.
- Presence of positive neurological diseases, such as stroke, brain tumor, dementia.
- Physically unable to attend the sessions of intervention.
- Currently enrolled in another intervention study.
- Currently taking a psychiatric or other medication that may affect sleep quality and cognition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Tai Po Hospital
Hong Kong
Yuk Shan Yuen, 85228314305, yukshanyuen@cuhk.edu.hk
About this study
Background: Subjective cognitive decline (SCD) is considered to be the early risk stage of dementia. Untreated SCD comorbid with sleep disturbances may accelerate the progression of neurodegeneration (β-amyloid and tau) and lead to cognitive deficits. At present, non-pharmacological interventions for managing SCD and sleep disturbances are very limited. High-definition slow-oscillatory transcranial direct current stimulation (so-tDCS) is a newly developed frequency-specific modality of brain stimulation for promoting brain health and cognition. Notably, neurophysiological feature (impedance) during tDCS was found to be related to treatment outcomes and adverse effects (skin injury). Objectives: We propose to 1) develop a high-performing neurophysiological signal detector for tDCS and test its feasibility and flexibility in a randomized clinical trial; 2) investigate the short-term and long-term effects of high-definition so-tDCS on SCD, sleep quality and plasma Aβ and p-tau levels; 3) examine the values of neurophysiological signals in predicting the treatment outcomes at individual level. Design: A randomized, double-blind, sham-controlled trial. Methods: Chinese right-handed older adults with SCD and sleep disturbances will be randomly assigned to a 4-week intervention of either high-definition 0.75 Hz so-tDCS or sham tDCS, with 40 participants per arm. Pre-treatment magnetic resonance imaging (MRI) scans will be collected to exclude the cases with major neurological disease and quantify individual's brain features. Galvanic skin response, subjective cognitive complaints, sleep quality, plasma p-tau and β-amyloid levels and domain-specific cognition will be assessed at baseline, 4th week, 8th week and 12th week. Program adherence and adverse effects will be monitored throughout the whole intervention.
Read the detailed description
This study aims to investigate the efficacy and sustainability of high-definition so-tDCS for managing SCD and sleep disturbances in older adults. The neurophysiological signal detector will be featured with a compact and high-performing GSR assessor with the state-of-the-art personalized measurement during so-tDCS. The successful implement of this signal detector will provide researchers assess to an "add-on" setting that allows them easily, quickly and quantitatively evaluate real-time neurophysiological signals and further incorporate transcranial brain stimulation in clinical practice.
- Conditions
- Subjective Cognitive Complaints (SCCs), Sleep
- Being tested
- so-tDCS, Sham so-tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
so-tDCSDevice
The so-tDCS is delivered by a battery driven direct current stimulator (DC-Stimulator Plus, NeuroConn, Ilmenau, Germany). The high-definition setting is applied by placing an anodal electrode over the center of the treatment target and placing four cathodal electrodes surrounded the anodal electrod. Each electrode in the "4 × 1" montages had a diameter of 1.2 cm. We place the anodal electrode over the center of left dorsolateral prefrontal cortex (DLPFC) (i.e., F3 according to the international 10-20 EEG system).
Sham so-tDCSDevice
Sham so-tDCS: With a same setting of high-definition as active so-tDCS, the stimulation of sham so-tDCS only lasts for 30 seconds. The electrodes will be left in place for a further 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Slow-oscillatory transcranial direct current stimulation | Active comparator | Not described Receives: Device: so-tDCS |
| Sham transcranial direct current stimulation | Sham comparator | Not described Receives: Device: Sham so-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impedance
A neurophysiological signal recorded and measured by a built-in wearable Galvanic Skin Response (GSR) sensor. The GSR sensor is placed on the fingers to detect the impedance of the skin when the participant is receiving the so-tDCS intervention
Measured: 12 weeks
Subjective cognitive complaints (SCC)
SCC is a 10-item questionnaire that covers subjective complaints in the core cognitive domains. Participants will answer ten yes/no questions relating to the presence of cognitive complaints in the last six months. The answers of SCC are codified as 0 (no complaints) or 1 (presence of complaints). Answers will be summed up and the total of complaints will be obtained ranging from 0 to 10.
Measured: 12 weeks
Pittsburg Sleep Quality Index (PSQI)
The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%). Greater score of PSQI indicates worse sleep quality.
Measured: 12 weeks
Secondary outcomes (3)
Intra-individual variability of reaction time (IIV-RT)
IIV-RT, representing the within-person fluctuations, is calculated based on the performance of attention network test (ANT). For correcting the increased RT in elderly, Intraindividual coefficient of variation of reaction time (ICV-RT) is used for assessing the IIV-RT enumerated with the formula: ICV-RT = (Standard deviation of RT/mean RT) × 100.
Measured: 12 weeks
Objective sleep quality
Actigraphy records will be used to quantify sleep-wake cycle during treatment.
Measured: 12 weeks
The levels of saliva Aβ
The levels of saliva Aβ , are assessed at the baseline and post-intervention time points.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive Complaints (SCCs)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LU Hanna, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433738
- Sponsor's protocol ID
- 2025.118
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lu H, Ni X, Yang NS, Yuen YS, Gong Y, Ma SL. Personalized assessment of high-definition slow-oscillatory transcranial direct current stimulation (so-tDCS) in older adults with sleep and subjective cognitive complaints: A study protocol for a randomized clinical trial. PLoS One. 2026 Oct 13;21(10):e0360573. doi: 10.1371/journal.pone.0360573. eCollection 2026.
PubMed 42868122
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Assessment of High-definition Slow-oscillatory Transcranial Direct Current Stimulation (So-tDCS) in Older Adults With Subjective Cognitive and Sleep Complaints
- ClinicalTrials.gov ID
- NCT07433738
- Acronym / sponsor ID
- 2025.118
- Conditions
- Subjective Cognitive Complaints (SCCs), Sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
Background: Subjective cognitive decline (SCD) is considered to be the early risk stage of dementia. Untreated SCD comorbid with sleep disturbances may accelerate the progression of neurodegeneration (β-amyloid and tau) and lead to cognitive deficits. At present, non-pharmacological interventions for managing SCD and sleep disturbances are very limited. High-definition slow-oscillatory transcranial direct current stimulation (so-tDCS) is a newly developed frequency-specific modality of brain stimulation for promoting brain health and cognition. Notably, neurophysiological feature (impedance) during tDCS was found to be related to treatment outcomes and adverse effects (skin injury). Objectives: We propose to 1) develop a high-performing neurophysiological signal detector for tDCS and test its feasibility and flexibility in a randomized clinical trial; 2) investigate the short-term and long-term effects of high-definition so-tDCS on SCD, sleep quality and plasma Aβ and p-tau levels; 3) examine the values of neurophysiological signals in predicting the treatment outcomes at individual level. Design: A randomized, double-blind, sham-controlled trial. Methods: Chinese right-handed older adults with SCD and sleep disturbances will be randomly assigned to a 4-week intervention of either high-definition 0.75 Hz so-tDCS or sham tDCS, with 40 participants per arm. Pre-treatment magnetic resonance imaging (MRI) scans will be collected to exclude the cases with major neurological disease and quantify individual's brain features. Galvanic skin response, subjective cognitive complaints, sleep quality, plasma p-tau and β-amyloid levels and domain-specific cognition will be assessed at baseline, 4th week, 8th week and 12th week. Program adherence and adverse effects will be monitored throughout the whole intervention.
Detailed description
This study aims to investigate the efficacy and sustainability of high-definition so-tDCS for managing SCD and sleep disturbances in older adults. The neurophysiological signal detector will be featured with a compact and high-performing GSR assessor with the state-of-the-art personalized measurement during so-tDCS. The successful implement of this signal detector will provide researchers assess to an "add-on" setting that allows them easily, quickly and quantitatively evaluate real-time neurophysiological signals and further incorporate transcranial brain stimulation in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow-oscillatory transcranial direct current stimulation | Active comparator | Device: so-tDCS |
| Sham transcranial direct current stimulation | Sham comparator | Device: Sham so-tDCS |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese, right-handed, aged from 60 to 85 years.
- Normal global cognition defined as a total score of the Montreal Cognitive Assessment Hong Kong version (HK MoCA) > 26.
- Subjective cognitive decline (SCD) is evaluated by a 10-item questionnaire that covers subjective cognitive complaints (SCC) in the core cognitive domains.
- Sleep disturbances or poor sleep quality is assessed and defined with a total score of the Pittsburgh Sleep Quality Index (PSQI) greater than 5.
Key exclusion criteria (7 listed)
- Previous diagnosis of age-related neurodegenerative diseases, such as Alzheimer's disease, Parkinson disease.
- History of neurological diseases including brain tumor, and stroke.
- History of psychiatric disorders including schizophrenia and depression.
- Presence of positive neurological diseases, such as stroke, brain tumor, dementia.
- Physically unable to attend the sessions of intervention.
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 |
|---|---|---|
| so-tDCSThe so-tDCS is delivered by a battery driven direct current stimulator (DC-Stimulator Plus, NeuroConn, Ilmenau, Germany). The high-definition setting is applied by placing an anodal electrode over the center of the treatment target and placing four cathodal electrodes surrounded the anodal electrod. Each electrode in the "4 × 1" montages had a diameter of 1.2 cm. We place the anodal electrode over the center of left dorsolateral prefrontal cortex (DLPFC) (i.e., F3 according to the international 10-20 EEG system). | Device | Slow-oscillatory transcranial direct current stimulation |
| Sham so-tDCSSham so-tDCS: With a same setting of high-definition as active so-tDCS, the stimulation of sham so-tDCS only lasts for 30 seconds. The electrodes will be left in place for a further 20 minutes. | Device | Sham transcranial direct current stimulation |
Primary outcome
Impedance
Time frame: 12 weeks
A neurophysiological signal recorded and measured by a built-in wearable Galvanic Skin Response (GSR) sensor. The GSR sensor is placed on the fingers to detect the impedance of the skin when the participant is receiving the so-tDCS intervention
Subjective cognitive complaints (SCC)
Time frame: 12 weeks
SCC is a 10-item questionnaire that covers subjective complaints in the core cognitive domains. Participants will answer ten yes/no questions relating to the presence of cognitive complaints in the last six months. The answers of SCC are codified as 0 (no complaints) or 1 (presence of complaints). Answers will be summed up and the total of complaints will be obtained ranging from 0 to 10.
Pittsburg Sleep Quality Index (PSQI)
Time frame: 12 weeks
The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%). Greater score of PSQI indicates worse sleep quality.
3 secondary outcomes
Intra-individual variability of reaction time (IIV-RT)
Time frame: 12 weeks
Objective sleep quality
Time frame: 12 weeks
The levels of saliva Aβ
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 42868122Lu H, Ni X, Yang NS, Yuen YS, Gong Y, Ma SL. Personalized assessment of high-definition slow-oscillatory transcranial direct current stimulation (so-tDCS) in older adults with sleep and subjective cognitive complaints: A study protocol for a randomized clinical trial. PLoS One. 2026 Oct 13;21(10):e0360573. doi: 10.1371/journal.pone.0360573. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing so-tDCS in people with Subjective Cognitive Complaints (SCCs) and Sleep, run by Chinese University of Hong Kong 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna LU, PhD (85228314305, hannalu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impedance (time frame: 12 weeks). The study lists 3 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 NCT07433738, which also lists 1 linked publication.
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 25 Feb 2026.