Healthy
Conditions
Keywords
tDCS rejection affect mood fMRI
Brief summary
This research study identifies neural pathways regulating negative moods during rejection by combining transcranial direct current stimulation (tDCS) and fMRI in a sample of healthy controls.
Detailed description
Aim 1: To test the behavioral effects of tDCS during social rejection. The first step will be to obtain behavioral effects of transcranial direct current stimulation (tDCS) during social rejection without functional magnetic resonance imaging (fMRI). Whereas previous studies used Cyberball (a computerized ball-tossing game that simulates social exclusion), we will use the Social Feedback Task. This task was created by Dr. Hsu to be more ethologically-relevant, has been shown to sustain negative moods during rejection and activates the right ventral lateral prefrontal cortex (rVLPFC) (preliminary fMRI data from 50 healthy controls in Dr. Hsu's previous study). Anodal tDCS will be applied over the right or left VLPFC to measure changes in mood during rejection and neutral conditions. Depending on results, alternate regions in separate subjects may also be stimulated: dorsolateral prefrontal cortex, insula, anterior cingulate cortex, pre-supplementary, and supplementary motor area \[all regions may be right or left hemisphere\]. All of these regions have been shown to be involved in emotion regulation. Questionnaires will be given before, during, and after the task to assess cognitive and emotional states. Aim 2: To identify neural pathways regulating negative moods during social rejection, using tDCS for activation and fMRI for assessment. Using a cross-over, sham-controlled design similar to previous tDCS+fMRI studies, we will measure the effects of anodal tDCS over the right or left VLPFC on neural activity and negative mood during rejection and neutral conditions. Alternate regions in separate subjects may also be stimulated including the dorsolateral prefrontal cortex, insula, anterior cingulate cortex, pre-supplementary, and supplementary motor area \[all regions may be right or left hemisphere\]. All of these regions have been shown to be involved in emotion regulation.
Interventions
DEVICEtDCS
tDCS
DEVICESham tDCS
Sham tDCS
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
within-subjects crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or females between 18 and 25 years old 2. No diagnosis on Axis I by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV. No current, or within the past 5 years. 3. Not currently in a romantic relationship 4. Ability to understand and follow instructions and oriented to name, time, and place. 5. No additional neurologic or psychiatric disorders 6. No current use of psychotropic drugs or during past 3 months (except marijuana and alcohol) 7. No current use of marijuana or during past 3 weeks 8. Not currently abusing alcohol 9. No history of alcohol or drug dependence within past 5 years 10. A negative urine pregnancy and toxicology screen. Verbal affirmation will be obtained (i.e., not pregnant and not currently using psychotropic drugs or during the past 3 months) during the Screening Visit (Day 1). Urine screen will be obtained on Days 2 and 3. If subject reports that there is a possibility that she is pregnant on Day 1 (Screening Visit) a urine pregnancy screen will be performed on that day. 11. (Women): If stopped or started oral contraceptives recently, at least 60 days on/off oral contraceptives.
Exclusion criteria
1. Left-handed or ambidextrous 2. Metallic dental implants 3. Metallic objects in the brain/skull 4. Medical device implants 5. Implanted electronic devices 6. History of seizures 7. History of strokes 8. Unexplained loss of consciousness 9. Frequent or severe headaches or neck pain 10. Clinically significant, uncontrolled liver, kidney, cardiac, or pulmonary disease 11. Terminal medical diagnosis consistent with survival \< 1 year 12. Pregnancy; childbirth or miscarriage within 6 months, breastfeeding within 6 months of recruitment 13. Serious mental impairment. Mini mental state exam of \< 23/30 14. Chronic skin disease 15. Previous experience with transcranial direct current stimulation (tDCS) 16. Regular tobacco use or tobacco use within past month 17. If using hormonal birth control, taking progestin-only pills (e.g., Cerazette, Ovrette), or Intrauterine devices (Mirena, Skyla), since progestin-only birth controls are more likely to cause mood swings. Addition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | 1-3 weeks | Images from fMRI scans for each participant are preprocessed (e.g., realigned, normalized, smoothed). Changes in BOLD signal are modeled for rejection and acceptance vs neutral blocks, and contrast images are created. These contrast images are used to compare tDCS vs sham for each subject in a within-subjects analysis. BOLD responses are reported as arbitrary units (i.e., change from sham stimulation). Regions of interest include left and right ventrolateral prefrontal cortex (VLPFC), left and right nucleus accumbens (NAcc), left and right amygdala (Amyg), left and right anterior insula (AI), left and right dorsal anterior cingulate cortex (dACC). |
| Change in Positive and Negative Affect Scale (During fMRI) | 1-3 weeks | Change in emotion will be measured on the Positive and Negative Affect Scale. During Rejection, Acceptance, and Neutral conditions, participants rate how much they feel sad, rejected, happy, and accepted on a visual analog scale from not at all (minimum score of 0) to extremely (maximum score of 100). Scores for sad were averaged with rejected, and scores for happy were averaged with accepted. The averaged scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant felt more of that particular emotion during a particular condition (minus neutral). Thus, a higher score for happy and accepted during the Acceptance-Neutral condition means a better outcome. Similarly, a lower score for happy and accepted' during Rejection-Neutral condition means a worse outcome. |
| Change in the Single-item Self-Esteem Scale (During fMRI) | 1-3 weeks | Change in self-esteem will be measured on the Single-item Self-Esteem Scale. During Rejection, Acceptance, and Neutral conditions, participants respond to the item I have high self-esteem on a visual analog scale from not at all true of me (minimum score of 0) to very true of me (maximum score of 100). Scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant had more self-esteem, and thus a better outcome, during a particular condition (minus neutral). |
| Change in Desire for Social Interaction Scale (During fMRI) | 1-3 weeks | Change in Desire for Social Interaction will be measured on the Desire for Social Interaction Scale. During Rejection, Acceptance, and Neutral conditions, participants respond to four items measuring desire for social interaction (e.g., I would enjoy social interaction right now) on a visual analog scale from very slightly or not at all (minimum score of 0) to extremely (maximum score of 100). Scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant had greater desire for social interaction, and thus a better outcome, during a particular condition (minus neutral). |
Countries
United States
Participant flow
Pre-assignment details
This was a within-subjects design, thus every subject received both active and sham conditions
Participants by arm
| Arm | Count |
|---|---|
| Sham tDCS tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the active treatment
Sham tDCS: Sham tDCS | 9 |
| Active tDCS tDCS stimulation will be administered over the brain area of interest
tDCS: tDCS | 7 |
| Total | 16 |
Baseline characteristics
| Characteristic | Sham tDCS | Active tDCS | Total |
|---|---|---|---|
| Age, Continuous | 21.89 years STANDARD_DEVIATION 2.37 | 21.71 years STANDARD_DEVIATION 1.8 | 21.81 years STANDARD_DEVIATION 2.07 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other or mixed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White or Caucasian | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units)
Images from fMRI scans for each participant are preprocessed (e.g., realigned, normalized, smoothed). Changes in BOLD signal are modeled for rejection and acceptance vs neutral blocks, and contrast images are created. These contrast images are used to compare tDCS vs sham for each subject in a within-subjects analysis. BOLD responses are reported as arbitrary units (i.e., change from sham stimulation). Regions of interest include left and right ventrolateral prefrontal cortex (VLPFC), left and right nucleus accumbens (NAcc), left and right amygdala (Amyg), left and right anterior insula (AI), left and right dorsal anterior cingulate cortex (dACC).
Time frame: 1-3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left VLPFC (Rejection-Neutral) | .57 Arbitrary units | Standard Deviation 0.77 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right VLPFC (Rejection-Neutral) | .25 Arbitrary units | Standard Deviation 0.49 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left VLPFC (Acceptance-Neutral) | .67 Arbitrary units | Standard Deviation 0.84 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right VLPFC (Acceptance-Neutral) | .40 Arbitrary units | Standard Deviation 1.14 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left NAcc (R-N) | .01 Arbitrary units | Standard Deviation 0.25 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right NAcc (R-N) | .05 Arbitrary units | Standard Deviation 0.3 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left NAcc (A-N) | .09 Arbitrary units | Standard Deviation 0.38 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right NAcc (A-N) | .17 Arbitrary units | Standard Deviation 0.38 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left Amyg (R-N) | .2 Arbitrary units | Standard Deviation 0.36 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right Amyg (R-N) | .19 Arbitrary units | Standard Deviation 0.41 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left Amyg (A-N) | .12 Arbitrary units | Standard Deviation 0.43 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right Amyg (A-N) | .07 Arbitrary units | Standard Deviation 0.43 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left AI (R-N) | .32 Arbitrary units | Standard Deviation 0.49 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right AI (R-N) | .28 Arbitrary units | Standard Deviation 0.49 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left AI (A-N) | .36 Arbitrary units | Standard Deviation 0.6 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right AI (A-N) | .21 Arbitrary units | Standard Deviation 0.86 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left dACC (R-N) | .04 Arbitrary units | Standard Deviation 0.6 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right dACC (R-N) | .13 Arbitrary units | Standard Deviation 0.45 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left dACC (A-N) | .09 Arbitrary units | Standard Deviation 0.6 |
| Sham tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right dACC (A-N) | .06 Arbitrary units | Standard Deviation 0.59 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right dACC (R-N) | .21 Arbitrary units | Standard Deviation 0.72 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left VLPFC (Rejection-Neutral) | .66 Arbitrary units | Standard Deviation 0.8 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left Amyg (A-N) | .11 Arbitrary units | Standard Deviation 0.23 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right VLPFC (Rejection-Neutral) | .29 Arbitrary units | Standard Deviation 0.38 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right AI (A-N) | .17 Arbitrary units | Standard Deviation 0.41 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left VLPFC (Acceptance-Neutral) | .33 Arbitrary units | Standard Deviation 0.77 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right Amyg (A-N) | .19 Arbitrary units | Standard Deviation 0.38 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right VLPFC (Acceptance-Neutral) | .31 Arbitrary units | Standard Deviation 0.72 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right dACC (A-N) | .32 Arbitrary units | Standard Deviation 0.67 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left NAcc (R-N) | .18 Arbitrary units | Standard Deviation 0.42 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left AI (R-N) | .38 Arbitrary units | Standard Deviation 0.53 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right NAcc (R-N) | .24 Arbitrary units | Standard Deviation 0.53 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left dACC (R-N) | .25 Arbitrary units | Standard Deviation 0.67 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left NAcc (A-N) | .27 Arbitrary units | Standard Deviation 0.38 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right AI (R-N) | .23 Arbitrary units | Standard Deviation 0.61 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right NAcc (A-N) | .34 Arbitrary units | Standard Deviation 0.58 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left dACC (A-N) | .42 Arbitrary units | Standard Deviation 0.62 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left Amyg (R-N) | .39 Arbitrary units | Standard Deviation 0.45 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | left AI (A-N) | .32 Arbitrary units | Standard Deviation 0.44 |
| Active tDCS | Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) | right Amyg (R-N) | .35 Arbitrary units | Standard Deviation 0.52 |
Primary
Change in Desire for Social Interaction Scale (During fMRI)
Change in Desire for Social Interaction will be measured on the Desire for Social Interaction Scale. During Rejection, Acceptance, and Neutral conditions, participants respond to four items measuring desire for social interaction (e.g., I would enjoy social interaction right now) on a visual analog scale from very slightly or not at all (minimum score of 0) to extremely (maximum score of 100). Scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant had greater desire for social interaction, and thus a better outcome, during a particular condition (minus neutral).
Time frame: 1-3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham tDCS | Change in Desire for Social Interaction Scale (During fMRI) | Rejection-Neutral conditions | -16.88 score on a scale | Standard Deviation 35.72 |
| Sham tDCS | Change in Desire for Social Interaction Scale (During fMRI) | Acceptance-Neutral conditions | -2.00 score on a scale | Standard Deviation 14.24 |
| Active tDCS | Change in Desire for Social Interaction Scale (During fMRI) | Acceptance-Neutral conditions | 1.33 score on a scale | Standard Deviation 19.22 |
| Active tDCS | Change in Desire for Social Interaction Scale (During fMRI) | Rejection-Neutral conditions | -13.75 score on a scale | Standard Deviation 30.3 |
Primary
Change in Positive and Negative Affect Scale (During fMRI)
Change in emotion will be measured on the Positive and Negative Affect Scale. During Rejection, Acceptance, and Neutral conditions, participants rate how much they feel sad, rejected, happy, and accepted on a visual analog scale from not at all (minimum score of 0) to extremely (maximum score of 100). Scores for sad were averaged with rejected, and scores for happy were averaged with accepted. The averaged scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant felt more of that particular emotion during a particular condition (minus neutral). Thus, a higher score for happy and accepted during the Acceptance-Neutral condition means a better outcome. Similarly, a lower score for happy and accepted' during Rejection-Neutral condition means a worse outcome.
Time frame: 1-3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Acceptance-Neutral conditions (sad and rejected) | 6.00 score on a scale | Standard Deviation 20.63 |
| Sham tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Rejection-Neutral conditions (sad and rejected) | 14.06 score on a scale | Standard Deviation 18.82 |
| Sham tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Rejection-Neutral conditions (happy and accepted) | -10.94 score on a scale | Standard Deviation 22.89 |
| Sham tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Acceptance-Neutral conditions (happy and accepted) | 0 score on a scale | Standard Deviation 22.2 |
| Active tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Acceptance-Neutral conditions (happy and accepted) | 12.00 score on a scale | Standard Deviation 25.48 |
| Active tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Acceptance-Neutral conditions (sad and rejected) | -3.33 score on a scale | Standard Deviation 13.84 |
| Active tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Rejection-Neutral conditions (happy and accepted) | -5.31 score on a scale | Standard Deviation 20.37 |
| Active tDCS | Change in Positive and Negative Affect Scale (During fMRI) | Rejection-Neutral conditions (sad and rejected) | 12.81 score on a scale | Standard Deviation 14.72 |
Primary
Change in the Single-item Self-Esteem Scale (During fMRI)
Change in self-esteem will be measured on the Single-item Self-Esteem Scale. During Rejection, Acceptance, and Neutral conditions, participants respond to the item I have high self-esteem on a visual analog scale from not at all true of me (minimum score of 0) to very true of me (maximum score of 100). Scores during Neutral were subtracted from Rejection and Acceptance to derive the outcome measures. Higher outcome measure score means that the participant had more self-esteem, and thus a better outcome, during a particular condition (minus neutral).
Time frame: 1-3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham tDCS | Change in the Single-item Self-Esteem Scale (During fMRI) | Rejection-Neutral conditions | -5.33 score on a scale | Standard Deviation 18.46 |
| Sham tDCS | Change in the Single-item Self-Esteem Scale (During fMRI) | Acceptance-Neutral conditions | 0.71 score on a scale | Standard Deviation 12.69 |
| Active tDCS | Change in the Single-item Self-Esteem Scale (During fMRI) | Rejection-Neutral conditions | -2.67 score on a scale | Standard Deviation 21.54 |
| Active tDCS | Change in the Single-item Self-Esteem Scale (During fMRI) | Acceptance-Neutral conditions | 8.57 score on a scale | Standard Deviation 28.78 |