Trial Outcomes & Findings for Activating and Identifying Neural Responses to Social Rejection: a Combined tDCS and fMRI Study (NCT NCT02739789)

Last Updated: 2020-07-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

1-3 weeks

Results posted on

2020-07-08

Participant Flow

This was a within-subjects design, thus every subject received both active and sham conditions

Participant milestones

Participant milestones
Measure	Sham tDCS First, Then Active tDCS Sham transcranial direct current stimulation (tDCS) on first scan day: tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment. Active tDCS on second scan day: tDCS stimulation will be administered over the brain area of interest.	Active tDCS First, Then Sham tDCS Active tDCS on first scan day: tDCS stimulation will be administered over the brain area of interest. Sham tDCS on second scan day: tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment.
First fMRI Scan STARTED	9	10
First fMRI Scan COMPLETED	9	10
First fMRI Scan NOT COMPLETED	0	0
~1 Week Waiting Period STARTED	9	10
~1 Week Waiting Period COMPLETED	9	7
~1 Week Waiting Period NOT COMPLETED	0	3
Second fMRI Scan STARTED	9	7
Second fMRI Scan COMPLETED	9	7
Second fMRI Scan NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Activating and Identifying Neural Responses to Social Rejection: a Combined tDCS and fMRI Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham tDCS n=9 Participants 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	Active tDCS n=7 Participants tDCS stimulation will be administered over the brain area of interest tDCS: tDCS	Total n=16 Participants Total of all reporting groups
Age, Continuous	21.89 years STANDARD_DEVIATION 2.37 • n=5 Participants	21.71 years STANDARD_DEVIATION 1.80 • n=7 Participants	21.81 years STANDARD_DEVIATION 2.07 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White or Caucasian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other or mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-3 weeks

Outcome measures

Outcome measures
Measure	Sham tDCS n=16 Participants 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	Active tDCS n=16 Participants tDCS stimulation will be administered over the brain area of interest tDCS: tDCS
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left VLPFC (Rejection-Neutral)	.57 Arbitrary units Standard Deviation .77	.66 Arbitrary units Standard Deviation .80
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right VLPFC (Rejection-Neutral)	.25 Arbitrary units Standard Deviation .49	.29 Arbitrary units Standard Deviation .38
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left VLPFC (Acceptance-Neutral)	.67 Arbitrary units Standard Deviation .84	.33 Arbitrary units Standard Deviation .77
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right VLPFC (Acceptance-Neutral)	.40 Arbitrary units Standard Deviation 1.14	.31 Arbitrary units Standard Deviation .72
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left NAcc (R-N)	.01 Arbitrary units Standard Deviation .25	.18 Arbitrary units Standard Deviation .42
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right NAcc (R-N)	.05 Arbitrary units Standard Deviation .30	.24 Arbitrary units Standard Deviation .53
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left NAcc (A-N)	.09 Arbitrary units Standard Deviation .38	.27 Arbitrary units Standard Deviation .38
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right NAcc (A-N)	.17 Arbitrary units Standard Deviation .38	.34 Arbitrary units Standard Deviation .58
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left Amyg (R-N)	.2 Arbitrary units Standard Deviation .36	.39 Arbitrary units Standard Deviation .45
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right Amyg (R-N)	.19 Arbitrary units Standard Deviation .41	.35 Arbitrary units Standard Deviation .52
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left Amyg (A-N)	.12 Arbitrary units Standard Deviation .43	.11 Arbitrary units Standard Deviation .23
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right Amyg (A-N)	.07 Arbitrary units Standard Deviation .43	.19 Arbitrary units Standard Deviation .38
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left AI (R-N)	.32 Arbitrary units Standard Deviation .49	.38 Arbitrary units Standard Deviation .53
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right AI (R-N)	.28 Arbitrary units Standard Deviation .49	.23 Arbitrary units Standard Deviation .61
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left AI (A-N)	.36 Arbitrary units Standard Deviation .60	.32 Arbitrary units Standard Deviation .44
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right AI (A-N)	.21 Arbitrary units Standard Deviation .86	.17 Arbitrary units Standard Deviation .41
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left dACC (R-N)	.04 Arbitrary units Standard Deviation .60	.25 Arbitrary units Standard Deviation .67
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right dACC (R-N)	.13 Arbitrary units Standard Deviation .45	.21 Arbitrary units Standard Deviation .72
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) left dACC (A-N)	.09 Arbitrary units Standard Deviation .6	.42 Arbitrary units Standard Deviation .62
Blood Oxygen Level Dependent (BOLD) Signal Changes (in Arbitrary Units) right dACC (A-N)	.06 Arbitrary units Standard Deviation .59	.32 Arbitrary units Standard Deviation .67

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham tDCS n=16 Participants 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	Active tDCS n=16 Participants tDCS stimulation will be administered over the brain area of interest tDCS: 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	12.81 score on a scale Standard Deviation 14.72
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	-3.33 score on a scale Standard Deviation 13.84
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	-5.31 score on a scale Standard Deviation 20.37
Change in Positive and Negative Affect Scale (During fMRI) Acceptance-Neutral conditions (happy and accepted)	0 score on a scale Standard Deviation 22.20	12.00 score on a scale Standard Deviation 25.48

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sham tDCS n=16 Participants 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	Active tDCS n=16 Participants tDCS stimulation will be administered over the brain area of interest tDCS: tDCS
Change in the Single-item Self-Esteem Scale (During fMRI) Rejection-Neutral conditions	-5.33 score on a scale Standard Deviation 18.46	-2.67 score on a scale Standard Deviation 21.54
Change in the Single-item Self-Esteem Scale (During fMRI) Acceptance-Neutral conditions	0.71 score on a scale Standard Deviation 12.69	8.57 score on a scale Standard Deviation 28.78

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sham tDCS n=16 Participants 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	Active tDCS n=16 Participants tDCS stimulation will be administered over the brain area of interest tDCS: tDCS
Change in Desire for Social Interaction Scale (During fMRI) Rejection-Neutral conditions	-16.88 score on a scale Standard Deviation 35.72	-13.75 score on a scale Standard Deviation 30.30
Change in Desire for Social Interaction Scale (During fMRI) Acceptance-Neutral conditions	-2.00 score on a scale Standard Deviation 14.24	1.33 score on a scale Standard Deviation 19.22

Adverse Events

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Hsu, Assistant Professor of Psychiatry

Stony Brook University

Phone: (631) 638-1522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place