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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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.

Li, PhD contact

39175655

chengli@hku.hk

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.

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 groups in NCT05501951
Study groupRoleWhat they receive
right DLPFC tDCSExperimentalParticipants in this group will receive 10 sessions of right DLPFC tDCS
Receives: Other: tDCS stimulation
right OFC tDCSExperimentalParticipants in this group will receive 10 sessions of right OFC tDCS
Receives: Other: tDCS stimulation
Control groupSham comparatorParticipants 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.

  1. 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.

  1. First posted16 Aug 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionAug 2023 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

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)
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

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.

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