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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tDCS | Sham Comparator | tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment |
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| Active tDCS | Active Comparator | tDCS stimulation will be administered over the brain area of interest |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | tDCS |
| |
| Sham tDCS |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
Addition Exclusion Criteria for participating in fMRI:
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| Name | Affiliation | Role |
|---|---|---|
| David T Hsu, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11794-8101 | United States |
This was a within-subjects design, thus every subject received both active and sham conditions
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First fMRI Scan |
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| ~1 Week Waiting Period |
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| Second fMRI Scan |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Active tDCS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Arbitrary units | 1-3 weeks |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham tDCS | Sham tDCS: tDCS stimulation will be administered over the brain area of interest, but will be shorter in duration than the "active" treatment. All participants received sham tDCS, either on the first or second scan day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Hsu, Assistant Professor of Psychiatry | Stony Brook University | (631) 638-1522 | david.hsu@stonybrookmedicine.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 21, 2020 | Apr 22, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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within-subjects crossover design
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| Device |
Sham tDCS |
|
| 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). | 1-3 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
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tDCS stimulation will be administered over the brain area of interest
tDCS: tDCS
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Active tDCS | tDCS stimulation will be administered over the brain area of interest tDCS: tDCS |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1-3 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 1-3 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 1-3 weeks |
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|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Active tDCS | Active tDCS: tDCS stimulation will be administered over the brain area of interest. All participants received active tDCS, either on the first or second scan day. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Rejection-Neutral conditions (happy and accepted) |
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| Acceptance-Neutral conditions (happy and accepted) |
|