An interventional study of tDCS and Sham tDCS in Healthy, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by Stony Brook University · Not applicable, Interventional, and Basic science
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.
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.
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Exclusion Criteria:
Addition Exclusion Criteria for participating in fMRI:
tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment
Device: Sham tDCS
tDCS stimulation will be administered over the brain area of interest
Device: tDCS
tDCS
Sham tDCS
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
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
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
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
| Milestone | Sham tDCS First, Then Active tDCS | Active tDCS First, Then Sham tDCS |
|---|---|---|
| Started | 9 | 10 |
| Completed | 9 | 10 |
| Not completed | 0 | 0 |
| Milestone | Sham tDCS First, Then Active tDCS | Active tDCS First, Then Sham tDCS |
|---|---|---|
| Started | 9 | 10 |
| Completed | 9 | 7 |
| Not completed | 0 | 3 |
| Milestone | Sham tDCS First, Then Active tDCS | Active tDCS First, Then Sham tDCS |
|---|---|---|
| Started | 9 | 7 |
| Completed | 9 | 7 |
| Not completed | 0 | 0 |
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).
| Arbitrary units | Sham tDCS | Active tDCS |
|---|---|---|
| left VLPFC (Rejection-Neutral) | .57 ± .77 | .66 ± .80 |
| right VLPFC (Rejection-Neutral) | .25 ± .49 | .29 ± .38 |
| left VLPFC (Acceptance-Neutral) | .67 ± .84 | .33 ± .77 |
| right VLPFC (Acceptance-Neutral) | .40 ± 1.14 | .31 ± .72 |
| left NAcc (R-N) | .01 ± .25 | .18 ± .42 |
| right NAcc (R-N) | .05 ± .30 | .24 ± .53 |
| left NAcc (A-N) | .09 ± .38 | .27 ± .38 |
| right NAcc (A-N) | .17 ± .38 | .34 ± .58 |
| left Amyg (R-N) | .2 ± .36 | .39 ± .45 |
| right Amyg (R-N) | .19 ± .41 | .35 ± .52 |
| left Amyg (A-N) | .12 ± .43 | .11 ± .23 |
| right Amyg (A-N) | .07 ± .43 | .19 ± .38 |
| left AI (R-N) | .32 ± .49 | .38 ± .53 |
| right AI (R-N) | .28 ± .49 | .23 ± .61 |
| left AI (A-N) | .36 ± .60 | .32 ± .44 |
| right AI (A-N) | .21 ± .86 | .17 ± .41 |
| left dACC (R-N) | .04 ± .60 | .25 ± .67 |
| right dACC (R-N) | .13 ± .45 | .21 ± .72 |
| left dACC (A-N) | .09 ± .6 | .42 ± .62 |
| right dACC (A-N) | .06 ± .59 | .32 ± .67 |
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.
| score on a scale | Sham tDCS | Active tDCS |
|---|---|---|
| Rejection-Neutral conditions (sad and rejected) | 14.06 ± 18.82 | 12.81 ± 14.72 |
| Acceptance-Neutral conditions (sad and rejected) | 6.00 ± 20.63 | -3.33 ± 13.84 |
| Rejection-Neutral conditions (happy and accepted) | -10.94 ± 22.89 | -5.31 ± 20.37 |
| Acceptance-Neutral conditions (happy and accepted) | 0 ± 22.20 | 12.00 ± 25.48 |
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).
| score on a scale | Sham tDCS | Active tDCS |
|---|---|---|
| Rejection-Neutral conditions | -5.33 ± 18.46 | -2.67 ± 21.54 |
| Acceptance-Neutral conditions | 0.71 ± 12.69 | 8.57 ± 28.78 |
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).
| score on a scale | Sham tDCS | Active tDCS |
|---|---|---|
| Rejection-Neutral conditions | -16.88 ± 35.72 | -13.75 ± 30.30 |
| Acceptance-Neutral conditions | -2.00 ± 14.24 | 1.33 ± 19.22 |
Collected over Adverse event data were collected over the duration of time over which each participant was assessed. This was an average of 30 days (standard deviation = 16 days, range = 14 - 74 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham tDCS | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Active tDCS | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Sham tDCS | Active tDCS | Total |
|---|---|---|---|
| Mean | 21.89 ± 2.37 | 21.71 ± 1.80 | 21.81 ± 2.07 |
| Sex: Female, Male(Participants) | Sham tDCS | Active tDCS | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 5 | 3 | 8 |
| Race/Ethnicity, Customized(Participants) | Sham tDCS | Active tDCS | Total |
|---|---|---|---|
| Race/Ethnicity — White or Caucasian | 5 | 3 | 8 |
| Race/Ethnicity — Black or African American | 0 | 1 | 1 |
| Race/Ethnicity — Hispanic or Latino | 0 | 0 | 0 |
| Race/Ethnicity — Asian | 3 | 3 | 6 |
| Race/Ethnicity — American Indian or Alaskan Native | 0 | 0 | 0 |
| Race/Ethnicity — Other or mixed | 1 | 0 | 1 |
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