Subthreshold DepressionNCT06517121
tDCS in People With Subthreshold Depression
A study testing Personalized Experimental Transcranial Direct Current Stimulation (tDCS) and Conventional Experimental Transcranial Direct Current Stimulation (tDCS) in people with Subthreshold Depression, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subthreshold Depression
- What is being tested?
- Personalized Experimental Transcranial Direct Current Stimulation (tDCS) and Conventional Experimental Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Jan 2026to Jan 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
- At least primary school education
- Subthreshold depression
Who cannot join
- On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
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, 1 recruiting
- Recruiting
The Education University of Hong Kong
Hong Kong
Nichol ML Wong, PhD, 852-29487431, nmlwong@eduhk.hk
About this study
Official title: Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.
Read the detailed description
Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood. Eligible participants will also be invited to receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a maximum of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing all the tDCS sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood. Eligible participants will also be invited to receive functional MRI scanning in the 3T MRI scanner again. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.
- Conditions
- Subthreshold Depression
- Being tested
- Personalized Experimental Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Conventional Experimental Transcranial Direct Current Stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Experimental Transcranial Direct Current Stimulation (tDCS)Device
This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing.
Sham Transcranial Direct Current Stimulation (tDCS)Device
This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation.
Conventional Experimental Transcranial Direct Current Stimulation (tDCS)Device
This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.
| Study group | Role | What they receive |
|---|---|---|
| Personalised tDCS group | Experimental | Participants who are assigned to the personalised group will receive anodal tDCS over a individualized stimulation site. Receives: Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS) |
| Conventional tDCS group | Experimental | Participants who are assigned to the Conventional group will receive anodal tDCS over F3. Receives: Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS) |
| Sham control group | Sham comparator | Participants who are assigned to the Conventional group will receive sham tDCS. The active stimulation will be delivered for the first 30 seconds only. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported loneliness
Loneliness is assessed based on the University of California, Los Angeles (UCLA) loneliness scale and single item, in which higher scores indicate greater degrees of loneliness.
Measured: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Secondary outcomes (4)
Changes in depressive symptoms
Depressive symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with a higher scores indicating higher severity
Measured: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in anxiety symptoms
Anxiety symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with a higher scores indicating higher severity
Measured: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in self-reported mood
Mood is assessed based on the Chinese Affect Scale, a 20-item 5-point Likert scale where participants rate the degree to which they currently feel the listed affects (scoring for each item: 0 = no at all; 4 = very).
Measured: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in brain activation and connectivity
Neural activities and connectivity in Ventral Attention Network, Frontoparietal Network, and Default Mode Network are assessed by functional MRI
Measured: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start16 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subthreshold DepressionStudies 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
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong, Hong Kong Baptist University
- Responsible party
- Principal investigator, WONG Man Lok Nichol, Education University of Hong Kong
- Investigators
- Nichol ML Wong, PhD, Principal investigator, Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517121
- Sponsor's protocol ID
- 2023-2024-0048
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression
- ClinicalTrials.gov ID
- NCT06517121
- Acronym / sponsor ID
- 2023-2024-0048
- Conditions
- Subthreshold Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong, Hong Kong Baptist University
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Jul 2024 (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.
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.
Detailed description
Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood. Eligible participants will also be invited to receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a maximum of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing all the tDCS sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood. Eligible participants will also be invited to receive functional MRI scanning in the 3T MRI scanner again. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalised tDCS group | Experimental | Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS)Participants who are assigned to the personalised group will receive anodal tDCS over a individualized stimulation site. |
| Conventional tDCS group | Experimental | Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS)Participants who are assigned to the Conventional group will receive anodal tDCS over F3. |
| Sham control group | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)Participants who are assigned to the Conventional group will receive sham tDCS. The active stimulation will be delivered for the first 30 seconds only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
- At least primary school education
- Subthreshold depression
Key exclusion criteria (1 listed)
- On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
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 |
|---|---|---|
| Personalized Experimental Transcranial Direct Current Stimulation (tDCS)This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing. | Device | Personalised tDCS group |
| Sham Transcranial Direct Current Stimulation (tDCS)This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation. | Device | Sham control group |
| Conventional Experimental Transcranial Direct Current Stimulation (tDCS)This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3. | Device | Conventional tDCS group |
Primary outcome
Changes in self-reported loneliness
Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Loneliness is assessed based on the University of California, Los Angeles (UCLA) loneliness scale and single item, in which higher scores indicate greater degrees of loneliness.
4 secondary outcomes
Changes in depressive symptoms
Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in anxiety symptoms
Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in self-reported mood
Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in brain activation and connectivity
Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
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 2 Feb 2026.
- 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.
Nichol ML Wong, PhD principal investigator
Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Experimental Transcranial Direct Current Stimulation (tDCS) and Conventional Experimental Transcranial Direct Current Stimulation (tDCS) in people with Subthreshold Depression, run by Education 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 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 Nichol ML Wong, PhD (852-29487431, nmlwong@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported loneliness (time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.