- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05937022
The Effects of Transcranial Direct Current Stimulation (tDCS) in Older Lonely Individuals
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tatia Mei-chun LEE, PhD
- Phone Number: (852) 3917-8394
- Email: tmclee@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Tatia Mei-chun LEE, PhD
- Phone Number: (852) 3917-8394
- Email: tmclee@hku.hk
-
Principal Investigator:
- Tatia Mei Chun Lee, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Right VLPFC tDCS
Participants who are assigned to the right VLPFC group will receive anodal tDCS over the right ventrolateral prefrontal cortex (VLPFC).
|
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.
|
Experimental: Left DLPFC tDCS
Participants who are assigned to the right VLPFC group will receive anodal tDCS over the left dorsolateral prefrontal cortex (DLPFC).
|
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 Comparator: Sham Control 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants' information-seeking and emotion-regulatory motivation will be measured with the Social Motivation Questionnaire (SMQ).
|
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.
|
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.
|
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.
|
The Participation Measure--3 Domains, 4 Dimensions (PM-3D4D) will assess participants' social participation.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
The Cognitive Emotion Regulation Questionnaire (CERQ) will assess participants' use of nine cognitive emotion regulation strategies.
|
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.
|
Coping Orientation to Problems Experienced Inventory (Brief-COPE) will assess participants' coping styles.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Cognitive control functions, specifically selective attention, will be assessed with the Chinese version (CST) of the Stroop Color Word Test (Victoria version).
|
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.
|
Processing Speed will be assessed with the Symbol Digit Modalities Test (SDMT).
|
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.
|
The Digit Span Backward Test will assess working memory.
|
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.
|
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).
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tatia Mei-chun LEE, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- hkutdcsage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Loneliness
-
University of RochesterNational Institute on Aging (NIA)Recruiting
-
Vladimíra DostálováBarcelona Institute for Global HealthRecruiting
-
Taipei Medical UniversityCompleted
-
Linkoeping UniversityUniversity College, LondonCompleted
-
KTO Karatay UniversityCompleted
-
Florida State UniversityCompleted
-
Heartfulness InstituteCompletedLonelinessUnited States
-
Trustees of Dartmouth CollegeRecruiting
-
University of OregonNational Institute on Drug Abuse (NIDA); HopeLab FoundationCompleted
Clinical Trials on Experimental Transcranial Direct Current Stimulation (tDCS)
-
Manhattan Psychiatric CenterCompletedSchizophrenia | Auditory HallucinationUnited States
-
Charite University, Berlin, GermanyTerminatedNeuralgia | Neuropathic PainGermany
-
D'Or Institute for Research and EducationCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsCompleted
-
Massachusetts General HospitalRecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
Oslo University HospitalCompleted
-
The National Brain Mapping Laboratory (NBML)Neuroelectrics Corporation; Leibniz-Institut für Arbeitsforschung; Zanjan University...CompletedDepressive Disorder | Cognitive Impairment | Psychiatric DisorderIran, Islamic Republic of
-
Hospital de Clinicas de Porto AlegreUnknownChronic Pain | EndometriosisBrazil
-
Pusan National University Yangsan HospitalRecruiting
-
VA Office of Research and DevelopmentRecruitingSuicide | ImpulsivityUnited States
-
VA Office of Research and DevelopmentRecruitingObesityUnited States