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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH118418 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).
Treatment-resistant binge eating and purging may be perpetuated by self-control deficits linked to reduced activation in frontostriatal circuits. To date, however, neurocognitive studies of BN have not assessed the dynamic computational processes underlying inhibition or considered the fact that individuals with BN oscillate between two extremes-under-controlled and over-controlled intake. The proposed study combines neuroimaging with computational modeling to investigate the influences of acute fasting and eating (i.e., metabolic states) on how the brains of women with bulimia nervosa (BN) adaptively prepare for and exert inhibitory control. More specifically, the study has the following main objectives: 1) To determine whether eating and fasting affect adaptive inhibitory control and related frontostriatal activation abnormally in BN; 2) To identify associations of BN severity with state-specific frontostriatal activation and behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Bulimia Nervosa | Other | Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. |
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| Participants without Bulimia Nervosa | Other | Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fasting state | Other | 16 hours of fasting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain Activation Associated With P(Stop) | Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely). | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
| Brain Activation Associated With Prediction Errors (Unsigned) | Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes). | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
| Brain Activation Associated With Prediction Errors (Signed) | Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control). | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Stop Signal Reaction Time (SSRT) | Behavioral performance on the stop signal task, as measured by stop signal reaction time calculated as mean go reaction time minus the stop-signal delay at 50% successful inhibition (SSD₅₀). Higher SSRT means longer latency before failed inhibition. | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
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Inclusion Criteria:
Additional Inclusion Criteria for Women with Bulimia Nervosa:
- Meet DSM-5 criteria for bulimia nervosa
Exclusion Criteria:
The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.
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| Name | Affiliation | Role |
|---|---|---|
| Laura A Berner, PhD | Department of Psychiatry, Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 24 months following peer-reviewed article publication
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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Subjects completed several screening processes to determine eligibility.
100 individuals were recruited (from New York City and the surrounding community and the Center of Excellence in Eating and Weight Disorders at Mount Sinai) and signed informed consent for the full study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Bulimia Nervosa | Participants with Bulimia Nervosa who signed consent |
| FG001 | Healthy Control Participants Without Bulimia Nervosa | Healthy Control Participants without Bulimia Nervosa who signed consent |
| FG002 | Bulimia Nervosa Fast Then Fed | Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). |
| FG003 | Bulimia Nervosa Fed Then Fast | Participants are scanned after a standardized meal on one day (Fed Scan) and are scanned after 16 hours of fasting (Fasted Scan) on a separate day, |
| FG004 | Healthy Control Fast Then Fed | Participants are scanned after 16 hours of fasting (Fasted Scan) on one day, and are scanned after a standardized meal on a separate day (Fed Scan). |
| FG005 | Healthy Control Fed Then Fast | Participants are scanned after a standardized meal on one day (Fed Scan) and are scanned after 16 hours of fasting (Fasted Scan) on a separate day, |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Prior to Randomization |
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| ||||||||||||||||||
| Randomization |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Bulimia Nervosa | Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants. |
| BG001 | Healthy Control Participants Without Bulimia Nervosa |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Brain Activation Associated With P(Stop) | Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely). | Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (>20% of TRs with ≥0.5mm framewise displacement) at one or both scans. | Posted | Mean | Standard Deviation | BOLD Signal | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
At baseline clinical interviews, the 16-hour fasting period before scan visits, and at the two scan visits (up to 3 weeks on average)
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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 | Participants With Bulimia Nervosa | Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reported Headache | Injury, poisoning and procedural complications | Non-systematic Assessment | Reported anticipated side effects from the fasting period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Berner | Icahn School of Medicine at Mount Sinai | 332-243-7259 | laura.berner@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | Nov 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2024 | Nov 5, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| D005215 | Fasting |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
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| fed state | Other | fed a standardized meal |
|
| magnetic resonance imaging | Other | neuroimaging with computational modeling |
|
|
| Brain Activation Associated With Successful Inhibition | Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials. Positive values indicate activation associated with successful inhibition. | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
| Stop Signal Task Inhibition | Percent correct responses to stop trials on the Stop Signal Task measured by percent of stop trials on which participant successfully withheld a response (vs. failed to withhold response). | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of objective binge eating episodes | Eating Disorder Examination (EDE): Frequency of objective binge eating episodes - number of times the behavior occurred (past 28 days) | For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any binge eating. | Mean | Standard Deviation | episodes in past 28 days |
|
| Number of self-induced vomiting episodes | EDE: Frequency of self-induced vomiting episodes - number of times the behavior occurred (past 28 days). | For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any purging behaviors. | Mean | Standard Deviation | number of episodes in the past 28 days |
|
| Number of fasting episodes | EDE: Frequency of fasting episodes - number of times the behavior occurred (past 28 days) | For healthy controls, EDE was administered to confirm healthy control status. Data not relevant in healthy controls, who by definition could not have any fasting episodes. | Mean | Standard Deviation | number of episodes in the past 28 days |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Participants With Bulimia Nervosa (Fasted Scan) | Participants are scanned after 16 hours of fasting (Fasted Scan) |
| OG001 | Participants With Bulimia Nervosa (Fed Scan) | Participants are scanned after a standardized meal (Fed Scan). |
| OG002 | Healthy Control Participants (Fasted Scan) | Participants are scanned after 16 hours of fasting (Fasted Scan) |
| OG003 | Healthy Control Participants (Fed Scan) | Participants are scanned after a standardized meal (Fed Scan). |
|
|
| Primary | Brain Activation Associated With Prediction Errors (Unsigned) | Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes). | Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (>20% of TRs with ≥0.5mm framewise displacement) at one or both scans. | Posted | Mean | Standard Deviation | BOLD Signal | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
|
|
|
| Primary | Brain Activation Associated With Prediction Errors (Signed) | Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control). | Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (>20% of TRs with ≥0.5mm framewise displacement) at one or both scans. | Posted | Mean | Standard Deviation | BOLD Signal | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
|
|
|
| Primary | Brain Activation Associated With Successful Inhibition | Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials. Positive values indicate activation associated with successful inhibition. | Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (>20% of TRs with ≥0.5mm framewise displacement) at one or both scans. | Posted | Mean | Standard Deviation | BOLD Signal | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
|
|
|
| Secondary | Stop Signal Reaction Time (SSRT) | Behavioral performance on the stop signal task, as measured by stop signal reaction time calculated as mean go reaction time minus the stop-signal delay at 50% successful inhibition (SSD₅₀). Higher SSRT means longer latency before failed inhibition. | Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (>20% of TRs with ≥0.5mm framewise displacement) at one or both scans. | Posted | Median | Standard Error | Milliseconds | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
|
|
|
| Secondary | Stop Signal Task Inhibition | Percent correct responses to stop trials on the Stop Signal Task measured by percent of stop trials on which participant successfully withheld a response (vs. failed to withhold response). | Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (>20% of TRs with ≥0.5mm framewise displacement) at one or both scans. | Posted | Median | Standard Error | percent correct responses | after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart) |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Healthy Control Participants Without Bulimia Nervosa | Participants were scanned after 16 hours of fasting (Fasted Scan) on one day, and were scanned after a standardized meal on a separate day (Fed Scan). The order of these fasted and fed visits was counterbalanced across participants. | 0 | 32 | 0 | 32 | 4 | 32 |
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| Potential structural abnormality identified on MRI | Nervous system disorders | Non-systematic Assessment | Incidental finding |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Left Caudate Brain Activation |
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| Left Putamen Brain Activation |
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| Left Dorsal ACC Activation |
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| Left VLPFC Brain Activation |
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| Right DLPFC Brain Activation |
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| Right Caudate Brain Activation |
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| Right Putamen Brain Activation |
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| Right Dorsal ACC Activation |
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| Right VLPFC Brain Activation |
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| Left Caudate Brain Activation |
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| Left Putamen Brain Activation |
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| Left Dorsal ACC Activation |
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| Left VLPFC Brain Activation |
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| Right DLPFC Brain Activation |
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| Right Caudate Brain Activation |
|
| Right Putamen Brain Activation |
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| Right Dorsal ACC Activation |
|
| Right VLPFC Brain Activation |
|
| Left Caudate Brain Activation |
|
| Left Putamen Brain Activation |
|
| Left Dorsal ACC Activation |
|
| Left VLPFC Brain Activation |
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| Right DLPFC Brain Activation |
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| Right Caudate Brain Activation |
|
| Right Putamen Brain Activation |
|
| Right Dorsal ACC Activation |
|
| Right VLPFC Brain Activation |
|