Risk-TakingNCT05501951
Reduce High-risk Behaviours Under Chronic Stress Via tDCS-induced Neural Plasticity
A study testing tDCS stimulation in people with Risk-Taking and Chronic Stress, run by LI Cheng.
Trial summary
The persistent political conflicts and COVID-19 pandemic have led to elevated chronic stress levels in Hong Kong, with far-reaching and profound negative impacts on the citizen's mental health. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk-Taking, Chronic Stress
- What is being tested?
- tDCS stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Jun 2024
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 21-40 years;
- Fluent in reading and writing Chinese (Cantonese or Mandarin);
- Right-handed as assessed with the Edinburgh Handedness Inventory;
- Normal or corrected-to-normal vision and hearing;
- IQ>90 as assessed with the Test of Nonverbal Intelligence, 4th edition (TONI-IV)
Who cannot join
- Past or present physical illness, organic brain disorder, traumatic brain injury, addiction, impulse control disorder, psychotic disorder, affective disorder, or any other major neurological or psychological condition;
- First-degree relative with past or present major psychological disorder or suicidal behaviour;
- Intake of psychotropic medication or any other medication that may affect cognition in the 6 months preceding the study day;
- (For women) being pregnant;
- any contraindication for tDCS, such as having a cerebral implant or history (either personal or family) of seizure. The psychological conditions will be assessed using the Structured Clinical Interview for DSM-5 Disorders-Clinician Version (SCID-5-CV).
Trial locations and contacts
No sites are listed yet.
About this study
The persistent political conflicts and COVID-19 pandemic have led to elevated chronic stress levels in Hong Kong, with far-reaching and profound negative impacts on the citizen's mental health. An important pathway via which chronic stress negatively impacts health is through promoting high-risk behaviours, such as addiction, suicide, and antisocial acts. Therefore, testing means to break the association between chronic stress and high-risk behaviour is essential to reducing the adverse consequences of stress and promoting stress resilience. The transcranial direct current stimulation (tDCS) may be a viable method for reducing risky tendency in high-stress individuals, through modulating brain functions and plasticity. Although single-session tDCS has been shown to reliably reduce risky decision making and behaviours acutely, its efficacy over extended periods of time has not been demonstrated, particularly among non-clinical samples. Being able to show that tDCS could lead to long-lasting reduction of risky tendency is necessary for promoting the wide application of this method in therapeutic settings. In this project, we aim to conduct a randomised control trial to systematically and comprehensively test whether 10 sessions of tDCS on either the dorsolateral prefrontal cortex or the orbitofrontal cortex would lead to reduction in risky tendency not only immediately after treatment, but also at 1 month and 3 months after treatment.
Participants will be healthy male and female adults (21-40 years old) under relatively high levels of chronic stress, as selected from an online survey prior to the study.
Read more
Participants will be randomly allocated to one of 3 treatment groups: DLPFC tDCS, OFC tDCS, and sham control. At baseline, participants will complete several risk-taking assessments, including an established computerised task that measures both risk taking and a cognitive bias that was shown to increase irrational risky tendency (illusion of control), an established questionnaire that measures risky decision making in real-life scenarios, and a scale measuring past engagement in common risky activities.
Participants will also complete various personality and mood questionnaires, along with assessments on important cognitive abilities. We hypothesized that both DLPFC and OFC tDCS would reduce risk taking across the 3 timepoints, but the effect of DLPFC tDCS would be mediated by reduction in cognitive bias, whereas that of OFC tDCS would be mediated by increase in inhibition functions. These hypotheses will be tested by linear mixed models and mediation analyses. Additional exploratory analyses also test whether the tDCS effect would be moderated by relevant personality factors such as impulsivity.
- Conditions
- Risk-Taking, Chronic Stress
- Being tested
- tDCS stimulation, Sham stimulation
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulationOther
The transcranial direct current stimulation (tDCS) method has emerged in the recent years as a non-invasive, safe, cheap, convenient and effective means to modulate brain functions and behaviours
Sham stimulationOther
For the sham group, the electrode positioning will be randomly allocated to be identical to either the DLPFC or the OFC group, and active stimulation will be delivered for the first 30 seconds only
| Study group | Role | What they receive |
|---|---|---|
| right DLPFC tDCS | Experimental | Participants in this group will receive 10 sessions of right DLPFC tDCS Receives: Other: tDCS stimulation |
| right OFC tDCS | Experimental | Participants in this group will receive 10 sessions of right OFC tDCS Receives: Other: tDCS stimulation |
| Control group | Sham comparator | Participants in this group will receive 10 sessions of sham stimulation Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in risk taking behavior
Changes in risk taking will be assessed using the IoC card gambling task
Measured: Baseline; 1-month follow up; 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk-TakingStudies 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, Investigator
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LI Cheng, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501951
- Sponsor's protocol ID
- tDCSHKU
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce High-risk Behaviours Under Chronic Stress Via tDCS-induced Neural Plasticity
- ClinicalTrials.gov ID
- NCT05501951
- Acronym / sponsor ID
- tDCSHKU
- Conditions
- Risk-Taking, Chronic Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- LI ChengUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The persistent political conflicts and COVID-19 pandemic have led to elevated chronic stress levels in Hong Kong, with far-reaching and profound negative impacts on the citizen's mental health. An important pathway via which chronic stress negatively impacts health is through promoting high-risk behaviours, such as addiction, suicide, and antisocial acts. Therefore, testing means to break the association between chronic stress and high-risk behaviour is essential to reducing the adverse consequences of stress and promoting stress resilience. The transcranial direct current stimulation (tDCS) may be a viable method for reducing risky tendency in high-stress individuals, through modulating brain functions and plasticity. Although single-session tDCS has been shown to reliably reduce risky decision making and behaviours acutely, its efficacy over extended periods of time has not been demonstrated, particularly among non-clinical samples. Being able to show that tDCS could lead to long-lasting reduction of risky tendency is necessary for promoting the wide application of this method in therapeutic settings. In this project, we aim to conduct a randomised control trial to systematically and comprehensively test whether 10 sessions of tDCS on either the dorsolateral prefrontal cortex or the orbitofrontal cortex would lead to reduction in risky tendency not only immediately after treatment, but also at 1 month and 3 months after treatment.
Participants will be healthy male and female adults (21-40 years old) under relatively high levels of chronic stress, as selected from an online survey prior to the study.
Participants will be randomly allocated to one of 3 treatment groups: DLPFC tDCS, OFC tDCS, and sham control. At baseline, participants will complete several risk-taking assessments, including an established computerised task that measures both risk taking and a cognitive bias that was shown to increase irrational risky tendency (illusion of control), an established questionnaire that measures risky decision making in real-life scenarios, and a scale measuring past engagement in common risky activities.
Participants will also complete various personality and mood questionnaires, along with assessments on important cognitive abilities. We hypothesized that both DLPFC and OFC tDCS would reduce risk taking across the 3 timepoints, but the effect of DLPFC tDCS would be mediated by reduction in cognitive bias, whereas that of OFC tDCS would be mediated by increase in inhibition functions. These hypotheses will be tested by linear mixed models and mediation analyses. Additional exploratory analyses also test whether the tDCS effect would be moderated by relevant personality factors such as impulsivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| right DLPFC tDCS | Experimental | Other: tDCS stimulationParticipants in this group will receive 10 sessions of right DLPFC tDCS |
| right OFC tDCS | Experimental | Other: tDCS stimulationParticipants in this group will receive 10 sessions of right OFC tDCS |
| Control group | Sham comparator | Other: Sham stimulationParticipants in this group will receive 10 sessions of sham stimulation |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 21-40 years;
- Fluent in reading and writing Chinese (Cantonese or Mandarin);
- Right-handed as assessed with the Edinburgh Handedness Inventory;
- Normal or corrected-to-normal vision and hearing;
- IQ>90 as assessed with the Test of Nonverbal Intelligence, 4th edition (TONI-IV)
Key exclusion criteria (5 listed)
- Past or present physical illness, organic brain disorder, traumatic brain injury, addiction, impulse control disorder, psychotic disorder, affective disorder, or any other major neurological or psychological condition;
- First-degree relative with past or present major psychological disorder or suicidal behaviour;
- Intake of psychotropic medication or any other medication that may affect cognition in the 6 months preceding the study day;
- (For women) being pregnant;
- any contraindication for tDCS, such as having a cerebral implant or history (either personal or family) of seizure. The psychological conditions will be assessed using the Structured Clinical Interview for DSM-5 Disorders-Clinician Version (SCID-5-CV).
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 |
|---|---|---|
| tDCS stimulationThe transcranial direct current stimulation (tDCS) method has emerged in the recent years as a non-invasive, safe, cheap, convenient and effective means to modulate brain functions and behaviours | Other | right DLPFC tDCS, right OFC tDCS |
| Sham stimulationFor the sham group, the electrode positioning will be randomly allocated to be identical to either the DLPFC or the OFC group, and active stimulation will be delivered for the first 30 seconds only | Other | Control group |
Primary outcome
Changes in risk taking behavior
Time frame: Baseline; 1-month follow up; 3-month follow up
Changes in risk taking will be assessed using the IoC card gambling task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation in people with Risk-Taking and Chronic Stress, run by LI Cheng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li, PhD (39175655, chengli@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in risk taking behavior (time frame: Baseline; 1-month follow up; 3-month follow up). 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 16 Aug 2022.