MoralityNCT04681391
tDCS, Moral Decision-Making, fMRI
An observational study of Morality, run by National Yang Ming Chiao Tung University Hospital.
Trial summary
Morality is the social rule about appropriateness of the behavior, containing concepts of justice, fairness, and rights. Previous studies suggested that the activation of right temporoparietal junction (rTPJ) should be involved in mental state reasoning in moral cognition. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Morality
- What is being tested?
- transCranial direct current stimulation
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2016to 10 Dec 2020
- Phase
- Observational
- 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 20 to 30 years
- All sexes
- Adult
Study population: Forty-two healthy volunteers (20 male; 22 female) without any history of psychiatry or neurological disorders (e.g., dementia, seizures), head injury, and alcohol or substance abuse, are all ethnic Chinese, right-handed, and aged between 20 to 30 years old (M = 23.476, SD = 2.211). They were recruited via the online survey sent to the student social group of National Yang-Ming University and National Taiwan University. Additionally, the study was approved by National Yang-Ming University Hospital, Yilan, Taiwan (IRB: 2016B008).
Who may be able to join
- healthy volunteers, are all ethnic Chinese, right-handed, and aged between 20 to 30 years old
Who cannot join
- any history of psychiatry or neurological disorders (e.g., dementia, seizures), head injury, and alcohol or substance abuse
About this study
Official title: The Role of Implicit Attitude in the tDCS Modulation on Moral Decision-Making
Morality is the social rule about appropriateness of the behavior, containing concepts of justice, fairness, and rights. Previous studies suggested that the activation of right temporoparietal junction (rTPJ) should be involved in mental state reasoning in moral cognition. Implicit moral attitude, which reflects people's fundamental beliefs about right and wrong, could be assessed by implicit association test on moral scenarios (mIAT), as indicated by the D scores. According to our previous findings, we postulate that, during moral decision-making, the high D group would have less rTPJ involvement and the low D group would have more. Here we applied tDCS, a non-invasive neuromodulation technique, to modulate cortical excitability in rTPJ.
Based on our postulation, we divided participants into high D and low D group and hypothesized that tDCS over rTPJ would modulate the behavior depending on the group. The results revealed that, in aspect of mIAT, implicit moral attitude could be modulated differently depending on the group via tDCS over rTPJ. In addition, hemodynamic response within rTPJ showed a main effect of tDCS while carrying out the helping behavior. In conclusion, these findings indicated that tDCS over rTPJ could modulate the implicit moral attitude as well as the rTPJ activity during moral action.
- Conditions
- Morality
- Being tested
- transCranial direct current stimulation
- Keywords
- tDCS, Moral Decision-Making, Implicit Attitude, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transCranial direct current stimulationDevice
In the present study, we applied DC Brain Stimulator Plus to stimulate right temporoparietal junction (rTPJ). The target electrode was placed over the location of rTPJ; on the other hand, the return electrode was placed over the left supraorbital area. That is, during anodal tDCS, the anode was placed over CP6, and the cathode was placed over left supraorbital area; conversely, during cathodal tDCS, the cathode was placed over CP6, and the anode was placed over left supraorbital area. For the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. On the other hand, same fade-in, fade-out, and current density were applied for the sham stimulation, but the duration of current-delivering only last 35 seconds. Therefore, participants could feel the skin sensation but did not have the after-effects of tDCS.
| Study group | Role | What they receive |
|---|---|---|
| anodal | For the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. During anodal tDCS, the anode was placed over right temporoparietal junction, and the cathode was placed over left supraorbital area. Receives: Device: transCranial direct current stimulation | |
| cathodal | For the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. During cathodal tDCS, the cathode was placed over right temporoparietal junction, and the anode was placed over left supraorbital area. Receives: Device: transCranial direct current stimulation | |
| sham (as a control condition) | same fade-in, fade-out, and current density were applied for the sham stimulation, but the duration of current-delivering only last 35 seconds. Receives: Device: transCranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Justice Sensitivity Inventory
Justice Sensitivity Inventory (JSI) is a self-report questionnaire which consists of four perspectives of justice sensitivity: victim, observer, beneficiary, and perpetrator (Schmitt, Baumert, Gollwitzer, \& Maes, 2010; Schmitt, Gollwitzer, Maes, \& Arbach, 2005). Each perspective contains ten descriptions, and participants would answer on a scale ranging from 1 (not at all) to 7 (exactly). Justice sensitivity reflects how people react to injustice and can be used to predict justice-related emotion and behavior (Baumert, Rothmund, Thomas, Gollwitzer, \& Schmitt, 2013).
Measured: 10 minutes
Morality Implicit Association Test
Implicit moral attitude was assessed by morality implicit association test (mIAT) in present study. The test was adapted from Implicit Association Test (IAT) developed by Greenwald and colleagues (1998). It measures the strength of the association 10 between target concepts and their associated attributes. In mIAT, target concepts were presented by morally good and morally bad clips, and attributes were presented by positive and negative words.
Measured: 15 minutes
Moral Action Task
To verify the modulation of rTPJ activity via tDCS and to examine whether this modulation would alter people's moral behavior, participants would take the perspective of the active role while viewing moral scenarios in the MRI scanner.
Forty-five dynamic visual stimuli from previous research were validated and applied in the Moral Action Task. Each animation consists of three still images with the respective duration of 1000ms, 200ms, and 200ms. These animations contain three kinds of moral scenarios: (1) a person who is taking an action to physically harm one another (perpetrating behavior); (2) a person who is alleviating the physical pain which the other one is suffered (helping behavior); and (3) a person who is carrying out an action that irrelevant to the other one (neural behavior). Additionally, the protagonists in these scenarios were all acting without the presence of faces, and therefore the participants would have no emotional clues for these social interactions.
Measured: 10 minutes
Secondary outcomes (1)
Moral Evaluation: Rating of Moral Action Task
Outside the MRI scanner, participants carried out the Moral Action Task again. They were instructed to imagine themselves as the actor in the animation and pressed the button just like they really did the moral actions. Moreover, they were asked how much guilt or warm-glow after doing the action. The ratings were on a visual analog scale ranging from 1 to 7 points (Yoder \& Decety, 2014).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start27 Dec 2016
- Primary completion30 Nov 2019
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MoralityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681391
- Sponsor's protocol ID
- 2016B008
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ciaramelli E, Muccioli M, Ladavas E, di Pellegrino G. Selective deficit in personal moral judgment following damage to ventromedial prefrontal cortex. Soc Cogn Affect Neurosci. 2007 Jun;2(2):84-92. doi: 10.1093/scan/nsm001.
PubMed 18985127FeldmanHall O, Mobbs D, Evans D, Hiscox L, Navrady L, Dalgleish T. What we say and what we do: the relationship between real and hypothetical moral choices. Cognition. 2012 Jun;123(3):434-41. doi: 10.1016/j.cognition.2012.02.001. Epub 2012 Mar 9.
PubMed 22405924Fumagalli M, Priori A. Functional and clinical neuroanatomy of morality. Brain. 2012 Jul;135(Pt 7):2006-21. doi: 10.1093/brain/awr334. Epub 2012 Feb 13.
PubMed 22334584Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Gaesser B, Hirschfeld-Kroen J, Wasserman EA, Horn M, Young L. A role for the medial temporal lobe subsystem in guiding prosociality: the effect of episodic processes on willingness to help others. Soc Cogn Affect Neurosci. 2019 May 17;14(4):397-410. doi: 10.1093/scan/nsz014.
PubMed 30809675Santiesteban I, Banissy MJ, Catmur C, Bird G. Enhancing social ability by stimulating right temporoparietal junction. Curr Biol. 2012 Dec 4;22(23):2274-7. doi: 10.1016/j.cub.2012.10.018. Epub 2012 Nov 1.
PubMed 23122848
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Implicit Attitude in the tDCS Modulation on Moral Decision-Making
- ClinicalTrials.gov ID
- NCT04681391
- Acronym / sponsor ID
- 2016B008
- Conditions
- Morality
- Keywords
- tDCS, Moral Decision-Making, Implicit Attitude, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 23 Dec 2020 (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.
Morality is the social rule about appropriateness of the behavior, containing concepts of justice, fairness, and rights. Previous studies suggested that the activation of right temporoparietal junction (rTPJ) should be involved in mental state reasoning in moral cognition. Implicit moral attitude, which reflects people's fundamental beliefs about right and wrong, could be assessed by implicit association test on moral scenarios (mIAT), as indicated by the D scores. According to our previous findings, we postulate that, during moral decision-making, the high D group would have less rTPJ involvement and the low D group would have more. Here we applied tDCS, a non-invasive neuromodulation technique, to modulate cortical excitability in rTPJ.
Based on our postulation, we divided participants into high D and low D group and hypothesized that tDCS over rTPJ would modulate the behavior depending on the group. The results revealed that, in aspect of mIAT, implicit moral attitude could be modulated differently depending on the group via tDCS over rTPJ. In addition, hemodynamic response within rTPJ showed a main effect of tDCS while carrying out the helping behavior. In conclusion, these findings indicated that tDCS over rTPJ could modulate the implicit moral attitude as well as the rTPJ activity during moral action.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anodal | – | Device: transCranial direct current stimulationFor the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. During anodal tDCS, the anode was placed over right temporoparietal junction, and the cathode was placed over left supraorbital area. |
| cathodal | – | Device: transCranial direct current stimulationFor the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. During cathodal tDCS, the cathode was placed over right temporoparietal junction, and the anode was placed over left supraorbital area. |
| sham (as a control condition) | – | Device: transCranial direct current stimulationsame fade-in, fade-out, and current density were applied for the sham stimulation, but the duration of current-delivering only last 35 seconds. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Forty-two healthy volunteers (20 male; 22 female) without any history of psychiatry or neurological disorders (e.g., dementia, seizures), head injury, and alcohol or substance abuse, are all ethnic Chinese, right-handed, and aged between 20 to 30 years old (M = 23.476, SD = 2.211). They were recruited via the online survey sent to the student social group of National Yang-Ming University and National Taiwan University. Additionally, the study was approved by National Yang-Ming University Hospital, Yilan, Taiwan (IRB: 2016B008).
Key inclusion criteria (1 listed)
- healthy volunteers, are all ethnic Chinese, right-handed, and aged between 20 to 30 years old
Key exclusion criteria (1 listed)
- any history of psychiatry or neurological disorders (e.g., dementia, seizures), head injury, and alcohol or substance abuse
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 |
|---|---|---|
| transCranial direct current stimulationIn the present study, we applied DC Brain Stimulator Plus to stimulate right temporoparietal junction (rTPJ). The target electrode was placed over the location of rTPJ; on the other hand, the return electrode was placed over the left supraorbital area. That is, during anodal tDCS, the anode was placed over CP6, and the cathode was placed over left supraorbital area; conversely, during cathodal tDCS, the cathode was placed over CP6, and the anode was placed over left supraorbital area. For the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. On the other hand, same fade-in, fade-out, and current density were applied for the sham stimulation, but the duration of current-delivering only last 35 seconds. Therefore, participants could feel the skin sensation but did not have the after-effects of tDCS. | Device | anodal, cathodal, sham (as a control condition) |
Primary outcome
Justice Sensitivity Inventory
Time frame: 10 minutes
Justice Sensitivity Inventory (JSI) is a self-report questionnaire which consists of four perspectives of justice sensitivity: victim, observer, beneficiary, and perpetrator (Schmitt, Baumert, Gollwitzer, \& Maes, 2010; Schmitt, Gollwitzer, Maes, \& Arbach, 2005). Each perspective contains ten descriptions, and participants would answer on a scale ranging from 1 (not at all) to 7 (exactly). Justice sensitivity reflects how people react to injustice and can be used to predict justice-related emotion and behavior (Baumert, Rothmund, Thomas, Gollwitzer, \& Schmitt, 2013).
Morality Implicit Association Test
Time frame: 15 minutes
Implicit moral attitude was assessed by morality implicit association test (mIAT) in present study. The test was adapted from Implicit Association Test (IAT) developed by Greenwald and colleagues (1998). It measures the strength of the association 10 between target concepts and their associated attributes. In mIAT, target concepts were presented by morally good and morally bad clips, and attributes were presented by positive and negative words.
Moral Action Task
Time frame: 10 minutes
To verify the modulation of rTPJ activity via tDCS and to examine whether this modulation would alter people's moral behavior, participants would take the perspective of the active role while viewing moral scenarios in the MRI scanner. Forty-five dynamic visual stimuli from previous research were validated and applied in the Moral Action Task. Each animation consists of three still images with the respective duration of 1000ms, 200ms, and 200ms. These animations contain three kinds of moral scenarios: (1) a person who is taking an action to physically harm one another (perpetrating behavior); (2) a person who is alleviating the physical pain which the other one is suffered (helping behavior); and (3) a person who is carrying out an action that irrelevant to the other one (neural behavior). Additionally, the protagonists in these scenarios were all acting without the presence of faces, and therefore the participants would have no emotional clues for these social interactions.
1 secondary outcome
Moral Evaluation: Rating of Moral Action Task
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 18985127Ciaramelli E, Muccioli M, Ladavas E, di Pellegrino G. Selective deficit in personal moral judgment following damage to ventromedial prefrontal cortex. Soc Cogn Affect Neurosci. 2007 Jun;2(2):84-92. doi: 10.1093/scan/nsm001.
- Background: PubMed 22405924FeldmanHall O, Mobbs D, Evans D, Hiscox L, Navrady L, Dalgleish T. What we say and what we do: the relationship between real and hypothetical moral choices. Cognition. 2012 Jun;123(3):434-41. doi: 10.1016/j.cognition.2012.02.001. Epub 2012 Mar 9.
- Background: PubMed 22334584Fumagalli M, Priori A. Functional and clinical neuroanatomy of morality. Brain. 2012 Jul;135(Pt 7):2006-21. doi: 10.1093/brain/awr334. Epub 2012 Feb 13.
- Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
- Results publication: PubMed 30809675Gaesser B, Hirschfeld-Kroen J, Wasserman EA, Horn M, Young L. A role for the medial temporal lobe subsystem in guiding prosociality: the effect of episodic processes on willingness to help others. Soc Cogn Affect Neurosci. 2019 May 17;14(4):397-410. doi: 10.1093/scan/nsz014.
- Results publication: PubMed 23122848Santiesteban I, Banissy MJ, Catmur C, Bird G. Enhancing social ability by stimulating right temporoparietal junction. Curr Biol. 2012 Dec 4;22(23):2274-7. doi: 10.1016/j.cub.2012.10.018. Epub 2012 Nov 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Morality, run by National Yang Ming Chiao Tung University Hospital.
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 1 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: finished, as of the sponsor's last update on 23 Dec 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Justice Sensitivity Inventory (time frame: 10 minutes). The study lists 3 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 NCT04681391, which also lists 6 linked publications.
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 23 Dec 2020.