LonelinessNCT05937022

The Effects of Transcranial Direct Current Stimulation (tDCS) in Older Lonely Individuals

A study testing Experimental Transcranial Direct Current Stimulation (tDCS) in people with Loneliness, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This randomized clinical trial aims to test the effects of 10 sessions of transcranial direct current stimulation (tDCS) on social and emotional functions in lonely older adults. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Loneliness
What is being tested?: 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: 135 participants
Where: 1 siteHong Kong
Study dates: 3 Dec 2022to Dec 2025
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged ≥ 60 years old;
Fluent in reading and speaking Traditional Chinese (Cantonese or Mandarin);
Right-handed as assessed with the Edinburgh Handedness Inventory;
Normal or corrected-to-normal vision and hearing;
Normal general cognitive function as determined by the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) ≥ 22;
≥ 9 years of formal education as lexical comprehension is required in the Emotion Rating Task.

Who cannot join

Current or past major physical or neurological illness that significantly affects the individual's current cognitive, motor, or brain function;
Medication or other treatment received within 2 weeks before the study that may affect the individual's current cognitive, motor, or brain function;
Receiving maintained therapy that may affect cognitive, motor, or brain function and cannot be discontinued for the entire course of study;
Past or present major psychological conditions, including affective disorders, anxiety disorder, psychotic disorder, addiction, and impulse control disorder;
Any contraindication of tDCS, such as a cerebral implant or history (either personal or family) of seizure.
Participation in similar brain stimulation studies within the past six months.

Trial locations and contacts

1 site in 1 country.

Tatia Mei-chun LEE, PhD contact

(852) 3917-8394

tmclee@hku.hk

Hong Kong1 site, 1 recruiting

The University of Hong Kong
Hong Kong
Tatia Mei-chun LEE, PhD, (852) 3917-8394, tmclee@hku.hk
Tatia Mei Chun Lee, PhD
Recruiting

Other trials in Hong Kong

About this study

Official title: Utilizing Transcranial Direct Current Stimulation (tDCS) to Boost Social Pleasure and Participation in Older Lonely Individuals

This randomized clinical trial aims to test the effects of 10 sessions of transcranial direct current stimulation (tDCS) on social and emotional functions in lonely older adults.

The main objectives include:

Understand whether tDCS could successfully boost positive social processing and social motivation in older adults, paralleling its effect on non-social reward processing;
Understand whether the reduced negative and increased positive social processing in older adults would translate to an increase in real-life social activity and a decrease in loneliness feeling;
Examine the intervention efficacy of tDCS among the aged population;
Understand whether the tDCS effect could be long-lasting (i.e., 1 and 3 months after intervention).

Participants will be lonely older adults aged 60 or above and screened on inclusion and exclusion criteria. Eligible participants will be randomly allocated to the left dorsolateral prefrontal cortex (DLPFC) tDCS group, the right ventrolateral prefrontal cortex (VLPFC) tDCS group, or the sham control group. Participants will complete an Emotion Rating Task, questionnaires assessing their psychosocial functions, and neuropsychological tests assessing their cognitive functions at baseline, after the 5th stimulation session, immediately after the 10th stimulation session, and 1 month and 3 months after the 10th stimulation session.

Read the detailed description

Loneliness, or perceived social isolation, results from discrepancies between an individual's desired and achieved social needs. A substantial proportion of older adults experience loneliness. With the social distancing policies implemented during the COVID-19 pandemic, older adults, who are more likely to be functionally dependent on their caregivers, have been primarily affected, contributing to adverse impacts on their social and emotional functions. As current loneliness interventions have shown limited efficacy, it is of great significance to test novel interventions for lonely older adults.

Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has demonstrated its safety and efficacy in modulating cortical excitability and associated behaviors in older adults. It has been suggested that repeated tDCS sessions show sustained therapeutic efficacy in chronic disorders. Additionally, the efficacy of tDCS as an intervention for lonely older adults has not been investigated. As a result, it is crucial to test repeated tDCS sessions as a potential intervention to reduce loneliness and improve socioemotional functions in lonely older adults.

Conditions: Loneliness
Being tested: Experimental Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
Keywords: Transcranial Direct Current Stimulation, Emotion Regulation, Lateral Prefrontal Cortex, Aging
Medical subject headings: Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Transcranial Direct Current Stimulation (tDCS)Device
This study will deliver tDCS sessions for ten sessions completed within two weeks. Consecutive tDCS sessions are separated by at least 24 hours. Participants assigned to one of the two experimental groups will receive 20 minutes of active stimulation with a 2mA intensity over the corresponding brain regions.
Sham Transcranial Direct Current Stimulation (tDCS)Device
This study will deliver tDCS sessions for ten sessions completed within two weeks. Consecutive tDCS sessions are separated by at least 24 hours. Participants assigned to the sham control group will receive 30 seconds of active stimulation over brain regions identical to either the left DLPFC or the right VLPFC experimental tDCS group.

Study groups in NCT05937022
Study group	Role	What they receive
Right VLPFC tDCS	Experimental	Participants who are assigned to the right VLPFC group will receive anodal tDCS over the right ventrolateral prefrontal cortex (VLPFC). Receives: Device: Experimental Transcranial Direct Current Stimulation (tDCS)
Left DLPFC tDCS	Experimental	Participants who are assigned to the right VLPFC group will receive anodal tDCS over the left dorsolateral prefrontal cortex (DLPFC). Receives: Device: Experimental Transcranial Direct Current Stimulation (tDCS)
Sham Control tDCS	Sham comparator	For the sham protocol, the electrode positioning will be randomly allocated to be identical to either the left DLPFC or the right VLPFC group, but 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 emotion and social motivation in response to social and non-social emotional stimuli
The Emotion Rating Task will assess participants' feelings and motivations upon seeing positive, negative, social, and non-social emotional words. Participants will need to rate on a scale regarding his/her emotional feelings and socializing motivation upon perceiving these words.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in self-reported loneliness levels
Perceived level of loneliness will be assessed with the brief 6-item UCLA Loneliness Scale. All items are scored on a 4-point scale ranging from 1 (never) to 4 (often). The total score ranges from 6 to 24. A higher score indicates a higher level of perceived loneliness.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.

Secondary outcomes (15)

Changes in social motivation
Participants' information-seeking and emotion-regulatory motivation will be measured with the Social Motivation Questionnaire (SMQ).
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in social anhedonia
The Dimensional Anhedonia Rating Scale (DARS) will assess participants' anhedonia in aspects including hobbies, dood/drink, social activities, and sensory experience. The participants will be instructed to provide at least two of their own examples for each pleasure domain. Participants will then be asked to rate items from 0 to 4 on a scale of not at all, slightly, moderately, mostly, and very much for each domain, with a lower score corresponding to a higher level of anhedonia.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in social participation
The Participation Measure--3 Domains, 4 Dimensions (PM-3D4D) will assess participants' social participation.
Measured: From baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in perceived social support
The Multidimensional Scale of Perceived Social Support (MSPSS) will assess participants' perceived social support. This scale includes 3 subscales: significant other, family, and friends. The mean score of the total scale can be obtained by summing across all 12 items and then dividing by 12. A higher score on the scale means a higher level of perceived social support.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in social isolation
The Abbreviated Lubben Social Network Scale (LSNS-6) will assess participants' social network size. The total score is the sum of the 6 items. Scores range from 0 to 30. A higher score indicates a lower level of social isolation.
Measured: From baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in positive and negative affect
Participants' emotional disposition and mood state will be measured with the Chinese Affect Scale (CAS). Participants will be instructed to rate on a scale from 0 to 4, with a higher score corresponding to a higher level of positive or negative affect. Scores of positive affect range from 0 to 40. Scores of negative affect range from 0 to 40.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in emotion regulation
The Cognitive Emotion Regulation Questionnaire (CERQ) will assess participants' use of nine cognitive emotion regulation strategies.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in coping styles
Coping Orientation to Problems Experienced Inventory (Brief-COPE) will assess participants' coping styles.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in approach and avoidance motivation
Participants' reward responsiveness, drive, fun-seeking, and punishment sensitivity will be assessed with the behavioral inhibition system and behavioral activation system (BIS/BAS) scale. The scale consists of 18 items that are rated on a 4-point Likert scale, with 1 = strongly disagree, 2 = disagree, 3 = agree, and 4 = strongly agree. Scores are calculated as the sum of respective items. A higher score indicates a higher approach or avoidance motivation.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in levels of depression
The Geriatric Depression Scale (GDS) will assess participants' levels of depression. Scores range from 0 to 30, with a higher score indicating a higher level of depression.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in levels of anxiety
The Geriatric Anxiety Scale - 10 Item Version (GAS-10) will assess participants' anxiety levels. Items 1 through 10 are summed to provide a total score. Each item ranges from 0 to 3. The total score ranges from 0 to 30.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in cognitive control functions
Cognitive control functions, specifically selective attention, will be assessed with the Chinese version (CST) of the Stroop Color Word Test (Victoria version).
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in processing speed
Processing Speed will be assessed with the Symbol Digit Modalities Test (SDMT).
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in working memory
The Digit Span Backward Test will assess working memory.
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in perceived levels of social and emotional loneliness
The self-reported social and emotional loneliness levels will be measured with the 6-item De Jong Gierveld Loneliness Scale. On the negatively worded items (1 to 3, emotional loneliness), the neutral and positive answers are scored as "1". On the positively worded items (4 to 6, social loneliness), the neutral and negative answers are scored as "1". Total score ranges from 0 (least lonely) to 6 (most lonely).
Measured: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month 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.

3 Dec 2022Dec 2025

First posted10 Jul 2023
Study start3 Dec 2022
Primary completionDec 2024 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LonelinessStudies of the same condition, open and under way.
More trials run by The 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
Model description: Participants are assigned to three groups in parallel for the duration of the study.
Masking: Single blind
Who is masked: Participant
Enrolment: 135 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05937022
Sponsor's protocol ID: hkutdcsage
Status last verified: Jul 2023
First submitted: 8 Jun 2023
Last updated: 12 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Tatia Mei-chun LEE, PhD

(852) 3917-8394

tmclee@hku.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing Transcranial Direct Current Stimulation (tDCS) to Boost Social Pleasure and Participation in Older Lonely Individuals
ClinicalTrials.gov ID: NCT05937022
Acronym / sponsor ID: hkutdcsage
Conditions: Loneliness
Keywords: Transcranial Direct Current Stimulation, Emotion Regulation, Lateral Prefrontal Cortex, Aging
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 135 participants (estimated)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: 3 Dec 2022 (actual)
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 10 Jul 2023 (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 randomized clinical trial aims to test the effects of 10 sessions of transcranial direct current stimulation (tDCS) on social and emotional functions in lonely older adults.

The main objectives include:

Understand whether tDCS could successfully boost positive social processing and social motivation in older adults, paralleling its effect on non-social reward processing;
Understand whether the reduced negative and increased positive social processing in older adults would translate to an increase in real-life social activity and a decrease in loneliness feeling;
Examine the intervention efficacy of tDCS among the aged population;
Understand whether the tDCS effect could be long-lasting (i.e., 1 and 3 months after intervention).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Participants are assigned to three groups in parallel for the duration of the study.

Arm	Type	Receives
Right VLPFC tDCS	Experimental	Device: Experimental Transcranial Direct Current Stimulation (tDCS)Participants who are assigned to the right VLPFC group will receive anodal tDCS over the right ventrolateral prefrontal cortex (VLPFC).
Left DLPFC tDCS	Experimental	Device: Experimental Transcranial Direct Current Stimulation (tDCS)Participants who are assigned to the right VLPFC group will receive anodal tDCS over the left dorsolateral prefrontal cortex (DLPFC).
Sham Control tDCS	Sham comparator	Device: Sham Transcranial Direct Current Stimulation (tDCS)For the sham protocol, the electrode positioning will be randomly allocated to be identical to either the left DLPFC or the right VLPFC group, but the active stimulation will be delivered for the first 30 seconds only.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Aged ≥ 60 years old;
Fluent in reading and speaking Traditional Chinese (Cantonese or Mandarin);
Right-handed as assessed with the Edinburgh Handedness Inventory;
Normal or corrected-to-normal vision and hearing;
Normal general cognitive function as determined by the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) ≥ 22;

Key exclusion criteria (6 listed)

Current or past major physical or neurological illness that significantly affects the individual's current cognitive, motor, or brain function;
Medication or other treatment received within 2 weeks before the study that may affect the individual's current cognitive, motor, or brain function;
Receiving maintained therapy that may affect cognitive, motor, or brain function and cannot be discontinued for the entire course of study;
Past or present major psychological conditions, including affective disorders, anxiety disorder, psychotic disorder, addiction, and impulse control disorder;
Any contraindication of tDCS, such as a cerebral implant or history (either personal or family) of seizure.

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
Experimental Transcranial Direct Current Stimulation (tDCS)This study will deliver tDCS sessions for ten sessions completed within two weeks. Consecutive tDCS sessions are separated by at least 24 hours. Participants assigned to one of the two experimental groups will receive 20 minutes of active stimulation with a 2mA intensity over the corresponding brain regions.	Device	Left DLPFC tDCS, Right VLPFC tDCS
Sham Transcranial Direct Current Stimulation (tDCS)This study will deliver tDCS sessions for ten sessions completed within two weeks. Consecutive tDCS sessions are separated by at least 24 hours. Participants assigned to the sham control group will receive 30 seconds of active stimulation over brain regions identical to either the left DLPFC or the right VLPFC experimental tDCS group.	Device	Sham Control tDCS

Primary outcome

Changes in emotion and social motivation in response to social and non-social emotional stimuli
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
The Emotion Rating Task will assess participants' feelings and motivations upon seeing positive, negative, social, and non-social emotional words. Participants will need to rate on a scale regarding his/her emotional feelings and socializing motivation upon perceiving these words.
Changes in self-reported loneliness levels
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Perceived level of loneliness will be assessed with the brief 6-item UCLA Loneliness Scale. All items are scored on a 4-point scale ranging from 1 (never) to 4 (often). The total score ranges from 6 to 24. A higher score indicates a higher level of perceived loneliness.

15 secondary outcomes

Changes in social motivation
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in social anhedonia
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in social participation
Time frame: From baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in perceived social support
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in social isolation
Time frame: From baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in positive and negative affect
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in emotion regulation
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in coping styles
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in approach and avoidance motivation
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in levels of depression
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in levels of anxiety
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in cognitive control functions
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in processing speed
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in working memory
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.
Changes in perceived levels of social and emotional loneliness
Time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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.

Tatia Mei-chun LEE, PhD contact

(852) 3917-8394

tmclee@hku.hk

Tatia Mei-chun LEE, PhD principal investigator

The 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 Experimental Transcranial Direct Current Stimulation (tDCS) in people with Loneliness, run by The 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 6 inclusion and 6 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 12 Jul 2023. 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 Tatia Mei-chun LEE, PhD ((852) 3917-8394, tmclee@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in emotion and social motivation in response to social and non-social emotional stimuli (time frame: From baseline to after the 5th tDCS session (1 week); from baseline to after the 10th tDCS session (2 weeks); from baseline to 1 month after the last tDCS session; from baseline to 3 months after the last tDCS session.). The study lists 2 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 NCT05937022.

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 12 Jul 2023.