Bipolar Disorder, Borderline Personality Disorder, Cutting, Depression, Non Suicidal Self Inflicted Injury, Non-Suicidal Self Injury, Self Harm, Self-inflicted Injury, Self-Injurious Behavior, Self Injurious Behavior Without Suicidal Intent, Self-injury
Conditions
Keywords
Transcranial direct current stimulation, Transcranial electric stimulation, non-invasive brain stimulation, tDCS
Brief summary
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). Individuals who engage in frequent NSSI will be randomized to 12 administrations of an active vs. inactive form of tDCS, paired with an Attention Training Technique task, over a two-week period. Functional MRI may be performed before and after this two week period. NSSI urges and behaviors will be monitored before, during, and after the period of tDCS administrations.
Detailed description
The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). NSSI is the deliberate attempt to harm oneself, most often through cutting or burning, without suicidal intent. NSSI is a maladaptive emotion-regulation strategy often triggered by negative emotions, especially those involving feelings of rejection. tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. Several studies have demonstrated its effectiveness in treating an array of conditions, depending on electrode placement, including depression and chronic pain. tDCS may also facilitate adaptive emotion regulation; researchers have also successfully used tDCS to reduce negative emotions and aggressive responses to social rejection. The investigators therefore seek to explore tDCS as a potential treatment for NSSI. This pilot feasibility study seeks 1) to examine how tDCS is tolerated in a sample of individuals who engage in frequent NSSI; 2) to gather pilot data regarding changes in emotional and neural responses during a social task after a series of tDCS sessions in this clinical population of individuals who engage in NSSI; 3) to gather pilot data on the effects of tDCS on NSSI behaviors and urges. The investigators seek to recruit a sample of 22 individuals who engage in frequent NSSI to complete all study procedures. Individuals will be randomized to receive active- or sham-tDCS for two twenty-minute applications on each of six alternating sessions over approximately two weeks for a total of 12 tDCS administrations, each paired with an Attention Training Task. Functional MRI (fMRI) may be performed at baseline and again after the completion of 12 applications of tDCS. Subjects' NSSI and urges to engage in NSSI will be recorded for four weeks in real-time, using an iPod- based system that reminds subjects to stop at certain times during the day to record their thoughts, feelings, and behaviors. This will allow measurement of NSSI urges and behaviors for one week before, two weeks during, and one week after the tDCS intervention. The long-term goal of this study is to identify a novel form of treatment for NSSI and to better understand NSSI pathophysiology.
Interventions
DEVICETranscranial direct current stimulation
tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes.
OTHERNo intervention
No intervention for participants who discontinued prior to randomization
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
tDCS device programmed with codes to deliver active vs. sham tDCS in a blinded manner. Individual independent of study team managed randomization and provided codes for blinded tDCS administration.
Intervention model description
Double-blind, randomized, sham-controlled trial. 2 arms of clinical trial. Listing 3 arms to include an arm for individuals who signed consent but discontinued prior to randomization and clinical intervention, to describe available data and adverse events in this group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-60 2. Frequent current NSSI (including cutting in which the skin is broken; self-hitting in which there is bruising; or burning in which there is evidence of a burn. Will not enroll if skin-picking or scratching is the only form of self-injury): has engaged in ≥2 episodes of NSSI in the two months prior to enrollment 3. Capacity to provide informed consent 4. If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer. 5. Normal hearing. 6. Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -
Exclusion criteria
1. Unstable medical conditions based on medical history or physical examination 2. Current psychotic disorder, mania, hypomania, intellectual disability 3. Dermatologic condition resulting in non-intact skin on the scalp 4. Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient 5. Pregnancy, currently lactating, or planning to conceive during the course of study participation. 6. A neurological disease or prior head trauma with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score ≥ 1.5 standard deviations below the mean on the Trailmaking A&B will be excluded from study participation. 7. Current alcohol or substance use disorder that is severe according to DSM-V criteria 8. Individuals who initiated or increased the dose of concurrent psychiatric medications (including antidepressants, anxiolytics, antipsychotic medications, mood stabilizers, and benzodiazepines) within two weeks prior to enrollment 9. Individuals who initiated psychotherapy within two weeks prior to enrollment 10. Current seizure disorder. 11. Use of anticonvulsant medications that target the GABA system (e.g., gabapentin). 12. Individuals currently using benzodiazepines who are unwilling or unable to refrain from the use of benzodiazepine medications for at least 72 hours before the first tDCS session and throughout the duration of the 2-week tDCS intervention. 13. Metal implants or paramagnetic objects contained within the body (including heart pacemaker, shrapnel, or surgical prostheses) which may present a risk to the subject or interfere with the MRI scan, according to the guidelines set forth in the following reference book commonly used by neuroradiologists: Guide to MR procedures and metallic objects, F.G. Shellock, Lippincott Williams and Wilkins NY 2001. Additionally transdermal patches will be removed during the MR study at the discretion of the investigator. 14. Claustrophobia significant enough to interfere with MRI scanning 15. Weight that exceeds 325 lbs or inability to fit into MRI scanner 16. Suicide attempt within the past 3 months 17. Serious self-harm resulting in hospitalization within the past 3 months. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Injurious Thoughts and Behaviors Inventory Part 4 | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) | Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported here: sitbi 61: What is the likelihood you will have thoughts about engaging in NSSI in the future? (0: very unlikely to 4: very likely) sitbi 72: What do you think is the likelihood you will engage in NSSI in the future? (0: very unlikely to 4: very likely) |
| Social Processing (Cyberball) fMRI Task: fMRI Responses | Pre-treatment (baseline) and post-treatment (up to 2 weeks) | The Cyberball task is a task used during functional MRI scanning. During the task, individuals play a virtual ball-tossing game, playing catch with two computer avatars, and have a social exclusion experience when the avatars stop tossing the ball to them. The outcome measure is a subtraction of a measure of brain activity (fMRI BOLD signal) during portions of the task when the individual is included in the virtual ball-tossing game as compared to periods when the individual is excluded (i.e. fMRI BOLD signal inclusion periods - fMRI BOLD signal exclusion periods). This is quantified in 7 specific brain regions specified in the table below. dACC = dorsal anterior cingulate. vlPFC = ventrolateral prefrontal cortex. AI = anterior insula. The unit of measurement is a beta-weight from a general linear model (a statistical model) and a higher value reflects greater activity in a given brain region during experiences of social exclusion as compared to social inclusion. |
| Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS) | EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Scores, coded on a scale from 1-5, are averaged across all prompts during the time period (baseline, during tDCS, post-tDCS). A higher score indicates more severe symptoms except for success at resisting thoughts, which is reverse-coded. |
| Self Injurious Thoughts and Behaviors Inventory Part 1 | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) | Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported in this table: Sitbi 58: At their worst, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe) sitbi 59: On average, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe) |
| Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS) | EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Items refer to the proportion of survey responses in which an individual endorsed the given thought or behavior or attempted to resist NSSI thoughts since the previous response (0 to 1), with yes scored as 1 and no scored as a zero. |
| Self Injurious Thoughts and Behaviors Inventory Part 2 | pre-treatment (baseline) and post-treatment (up to 2 weeks) | Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 68: How many times \[did you self-injure\] in the past week? (number entered, minimum = 0, maximum = no limit) |
| Self Injurious Thoughts and Behaviors Inventory Part 3 | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) | Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 60: When you have had these thoughts: how long have they usually lasted? (0: 0 seconds to 6: more than 2 days) |
Other
| Measure | Time frame | Description |
|---|---|---|
| tDCS Adverse Effects Questionnaire | Administered after each (12) tDCS session over 6 days | A questionnaire to evaluate side-effects related to tDCS administration. This questionnaire asks about the presence and severity of possible side-effects of tDCS procedures, and was recently published as a gold-standard tool for this purpose: Aparício LVM, Guarienti F, Razza LB, Carvalho AF, Fregni F, Brunoni AR. A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Brain Stimul. 2016 Oct;9(5):671-81. This is an 11-item scale, that asks about the occurrence and severity of a range of possible side-effects during or after tDCS administration. Each side-effect can be rated as absent, mild, moderate, or severe. Summary data regarding the number of participants who endorsed a listed side-effect from the scale during at least one tDCS administration are presented here. Each participant was asked about the presence and severity of all listed side-effects after each administration of tDCS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) active anodal tDCS to ventrolateral prefrontal cortex (VLPFC).
1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions
Transcranial direct current stimulation: tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. | 3 |
| Sham Anodal tDCS to VLPFC sham anodal tDCS to VLPFC
Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.
Transcranial direct current stimulation: tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. | 3 |
| Discontinued Prior to Randomization Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study
No intervention: No intervention for participants who discontinued prior to randomization | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC) | Total | Discontinued Prior to Randomization | Sham Anodal tDCS to VLPFC |
|---|---|---|---|---|
| Age, Continuous | 24.7 years STANDARD_DEVIATION 3.5 | 23.8 years STANDARD_DEVIATION 5 | 25.1 years STANDARD_DEVIATION 6 | 20 years STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 11 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 10 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 13 participants | 7 participants | 3 participants |
| Sex/Gender, Customized Female | 3 Participants | 10 Participants | 5 Participants | 2 Participants |
| Sex/Gender, Customized Male | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Non-Binary | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 7 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 0 / 7 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 2 / 7 |
Outcome results
Primary
Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior
EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Scores, coded on a scale from 1-5, are averaged across all prompts during the time period (baseline, during tDCS, post-tDCS). A higher score indicates more severe symptoms except for success at resisting thoughts, which is reverse-coded.
Time frame: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Success at resisting self-injury thoughts: post-tDCS | 0.6667 Average score on a scale | Standard Deviation 0.9428 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Duration of self-injury thoughts: during tDCS | 0.6770 Average score on a scale | Standard Deviation 0.3366 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Strength of self-injury thoughts: baseline | 1.2697 Average score on a scale | Standard Deviation 0.6952 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Duration of self-injury thoughts: post-tDCS | 0.3333 Average score on a scale | Standard Deviation 0.4714 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Difficulty resisting self-injury thoughts: baseline | 1.0587 Average score on a scale | Standard Deviation 0.6349 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Difficulty resisting self-injury thoughts: during tDCS | 1.0636 Average score on a scale | Standard Deviation 0.8165 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Difficulty resisting self-injury thoughts: post-tDCS | 0.5667 Average score on a scale | Standard Deviation 0.8014 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Success at resisting self-injury thoughts: baseline | 1.0774 Average score on a scale | Standard Deviation 0.8346 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Strength of self-injury thoughts: during tDCS | 1.1186 Average score on a scale | Standard Deviation 0.7094 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Success at resisting self-injury thoughts: during tDCS | 1.0476 Average score on a scale | Standard Deviation 0.8987 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Strength of self-injury thoughts: post-tDCS | 0.5667 Average score on a scale | Standard Deviation 0.8014 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Duration of self-injury thoughts: baseline | 0.9821 Average score on a scale | Standard Deviation 0.4538 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Success at resisting self-injury thoughts: post-tDCS | 0.4444 Average score on a scale | Standard Deviation 0.5092 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Strength of self-injury thoughts: post-tDCS | 1.38 Average score on a scale | Standard Deviation 0.9439 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Duration of self-injury thoughts: post-tDCS | 1.2307 Average score on a scale | Standard Deviation 0.9196 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Difficulty resisting self-injury thoughts: baseline | 1.0711 Average score on a scale | Standard Deviation 0.8945 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Difficulty resisting self-injury thoughts: post-tDCS | 0.7879 Average score on a scale | Standard Deviation 1.0654 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Strength of self-injury thoughts: baseline | 1.5285 Average score on a scale | Standard Deviation 1.0736 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Duration of self-injury thoughts: baseline | 1.2479 Average score on a scale | Standard Deviation 1.1492 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Duration of self-injury thoughts: during tDCS | 0.9503 Average score on a scale | Standard Deviation 0.9765 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Difficulty resisting self-injury thoughts: during tDCS | 0.9338 Average score on a scale | Standard Deviation 0.93 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Success at resisting self-injury thoughts: baseline | 0.8344 Average score on a scale | Standard Deviation 0.5786 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Success at resisting self-injury thoughts: during tDCS | 0.7404 Average score on a scale | Standard Deviation 0.6601 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior | Strength of self-injury thoughts: during tDCS | 1.2294 Average score on a scale | Standard Deviation 0.9414 |
Primary
Ecological Momentary Assessment (EMA): NSSI Urges and Behavior
EMA assessment of NSSI urges and behavior before, during, and after tDCS intervention. EMA is a tool through which participants can respond to a brief questionnaire on a smartphone device while going about their daily lives. Participants were prompted to complete a brief questionnaire 6 times per day over a 4 week period (one week before tDCS (baseline), 2 weeks during tDCS (during tDCS), and one week after the final tDCS administration (post-tDCS)), which asks questions about urges to engage in NSSI and in actual NSSI behavior. Items refer to the proportion of survey responses in which an individual endorsed the given thought or behavior or attempted to resist NSSI thoughts since the previous response (0 to 1), with yes scored as 1 and no scored as a zero.
Time frame: One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Attempted to resist self-injury thoughts: baseline | 0.3658 Proportion of prompts | Standard Deviation 0.2531 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Thoughts of self-injury: during tDCS | 0.4084 Proportion of prompts | Standard Deviation 0.2963 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Attempted to resist self-injury thoughts: during tDCS | 0.3509 Proportion of prompts | Standard Deviation 0.2937 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Attempted to resist self-injury thoughts: post-tDCS | 0.2 Proportion of prompts | Standard Deviation 0.2828 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Self-harm behavior: baseline | 0.0975 Proportion of prompts | Standard Deviation 0.1082 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Self-harm behavior: during tDCS | 0.1261 Proportion of prompts | Standard Deviation 0.1615 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Thoughts of self-injury: post-tDCS | 0.2333 Proportion of prompts | Standard Deviation 0.33 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Self-harm behavior: post-tDCS | 0.1 Proportion of prompts | Standard Deviation 0.1414 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Thoughts of self-injury: baseline | 0.4453 Proportion of prompts | Standard Deviation 0.2874 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Self-harm behavior: post-tDCS | 0.0967 Proportion of prompts | Standard Deviation 0.1343 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Attempted to resist self-injury thoughts: during tDCS | 0.2803 Proportion of prompts | Standard Deviation 0.2644 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Self-harm behavior: baseline | 0.1759 Proportion of prompts | Standard Deviation 0.1818 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Thoughts of self-injury: during tDCS | 0.3661 Proportion of prompts | Standard Deviation 0.2166 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Thoughts of self-injury: post-tDCS | 0.3937 Proportion of prompts | Standard Deviation 0.2379 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Attempted to resist self-injury thoughts: baseline | 0.3146 Proportion of prompts | Standard Deviation 0.247 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Attempted to resist self-injury thoughts: post-tDCS | 0.2071 Proportion of prompts | Standard Deviation 0.2608 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Self-harm behavior: during tDCS | 0.1073 Proportion of prompts | Standard Deviation 0.1298 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Ecological Momentary Assessment (EMA): NSSI Urges and Behavior | Thoughts of self-injury: baseline | 0.4664 Proportion of prompts | Standard Deviation 0.2274 |
Primary
Self Injurious Thoughts and Behaviors Inventory Part 1
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported in this table: Sitbi 58: At their worst, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe) sitbi 59: On average, how intense were your thoughts about engaging in NSSI? (0: very mild to 4: very severe)
Time frame: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | At their worst, how intense were your thoughts about engaging in self-harm? (sitbi 58) | 2.33 score on a scale | Standard Deviation 1.15 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | On average, how intense were your thoughts about engaging in self-harm? (sitbi 59) | 1.67 score on a scale | Standard Deviation 0.58 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | On average, how intense were your thoughts about engaging in self-harm? (sitbi 59) | 2 score on a scale | Standard Deviation 1 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | At their worst, how intense were your thoughts about engaging in self-harm? (sitbi 58) | 2.67 score on a scale | Standard Deviation 1.15 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | At their worst, how intense were your thoughts about engaging in self-harm? (sitbi 58) | 2.67 score on a scale | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | On average, how intense were your thoughts about engaging in self-harm? (sitbi 59) | 1.67 score on a scale | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | On average, how intense were your thoughts about engaging in self-harm? (sitbi 59) | 2.33 score on a scale | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 1 | At their worst, how intense were your thoughts about engaging in self-harm? (sitbi 58) | 2.67 score on a scale | Standard Deviation 1.15 |
Primary
Self Injurious Thoughts and Behaviors Inventory Part 2
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 68: How many times \[did you self-injure\] in the past week? (number entered, minimum = 0, maximum = no limit)
Time frame: pre-treatment (baseline) and post-treatment (up to 2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 2 | 4.33 Number of events | Standard Deviation 2.52 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 2 | 1.33 Number of events | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 2 | 9.67 Number of events | Standard Deviation 13.43 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 2 | 1.33 Number of events | Standard Deviation 2.31 |
Primary
Self Injurious Thoughts and Behaviors Inventory Part 3
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following item is reported in this table: sitbi 60: When you have had these thoughts: how long have they usually lasted? (0: 0 seconds to 6: more than 2 days)
Time frame: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 3 | 2.33 score on a scale | Standard Deviation 0.58 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 3 | 2.33 score on a scale | Standard Deviation 1.15 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 3 | 3.33 score on a scale | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 3 | 3.33 score on a scale | Standard Deviation 2.31 |
Primary
Self Injurious Thoughts and Behaviors Inventory Part 4
Selected items from the Self-Injurious Thoughts and Behaviors Interview (SITBI) were used at baseline and after the tDCS or sham intervention as outcome measures in this study. These items ask participants to report on their NSSI thoughts and behaviors over the past week. The following items are reported here: sitbi 61: What is the likelihood you will have thoughts about engaging in NSSI in the future? (0: very unlikely to 4: very likely) sitbi 72: What do you think is the likelihood you will engage in NSSI in the future? (0: very unlikely to 4: very likely)
Time frame: Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm thoughts (sitbi 61) | 4 score on a scale | Standard Deviation 0 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm (sitbi 72) | 4 score on a scale | Standard Deviation 0 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm (sitbi 72) | 3.33 score on a scale | Standard Deviation 0.58 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm thoughts (sitbi 61) | 33 score on a scale | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm thoughts (sitbi 61) | 4 score on a scale | Standard Deviation 0 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm (sitbi 72) | 3.67 score on a scale | Standard Deviation 0.58 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm thoughts (sitbi 61) | 4 score on a scale | Standard Deviation 0 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Self Injurious Thoughts and Behaviors Inventory Part 4 | Likelihood of future self-harm (sitbi 72) | 3.67 score on a scale | Standard Deviation 0.58 |
Primary
Social Processing (Cyberball) fMRI Task: fMRI Responses
The Cyberball task is a task used during functional MRI scanning. During the task, individuals play a virtual ball-tossing game, playing catch with two computer avatars, and have a social exclusion experience when the avatars stop tossing the ball to them. The outcome measure is a subtraction of a measure of brain activity (fMRI BOLD signal) during portions of the task when the individual is included in the virtual ball-tossing game as compared to periods when the individual is excluded (i.e. fMRI BOLD signal inclusion periods - fMRI BOLD signal exclusion periods). This is quantified in 7 specific brain regions specified in the table below. dACC = dorsal anterior cingulate. vlPFC = ventrolateral prefrontal cortex. AI = anterior insula. The unit of measurement is a beta-weight from a general linear model (a statistical model) and a higher value reflects greater activity in a given brain region during experiences of social exclusion as compared to social inclusion.
Time frame: Pre-treatment (baseline) and post-treatment (up to 2 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 281 (right vlPFC) | -234.9502234 beta-weight | Standard Deviation 454.57709537062 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 240 (right vlPFC) | -227.9885197 beta-weight | Standard Deviation 395.65696014195 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 247 (right AI) | -247.2044975 beta-weight | Standard Deviation 466.61315305963 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 183 (right dACC) | -651.4402542 beta-weight | Standard Deviation 1422.0518670889 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 241 (right vlPFC) | -335.4290303 beta-weight | Standard Deviation 565.88946960588 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 29 (left dACC) | -621.4739585 beta-weight | Standard Deviation 819.58606846675 |
| Sham Anodal tDCS to VLPFC: Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 242 (right vlPFC) | -756.0566932 beta-weight | Standard Deviation 956.69043909054 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 183 (right dACC) | -581.3360775 beta-weight | Standard Deviation 1419.488164156 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 240 (right vlPFC) | -203.971185 beta-weight | Standard Deviation 671.54324931238 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 242 (right vlPFC) | -297.5780364 beta-weight | Standard Deviation 1289.3740570339 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 247 (right AI) | -495.6796714 beta-weight | Standard Deviation 758.72874358403 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 281 (right vlPFC) | -229.4499879 beta-weight | Standard Deviation 706.9215679631 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 29 (left dACC) | -519.1597701 beta-weight | Standard Deviation 1187.3713291081 |
| Sham Anodal tDCS to VLPFC: Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 241 (right vlPFC) | -215.3886576 beta-weight | Standard Deviation 1194.5755014134 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 247 (right AI) | -127.9602427 beta-weight | Standard Deviation 1163.6302170131 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 242 (right vlPFC) | 320.32500074999 beta-weight | Standard Deviation 986.09839303323 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 241 (right vlPFC) | 50.34725113 beta-weight | Standard Deviation 456.40817606524 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 29 (left dACC) | -63.33972338 beta-weight | Standard Deviation 851.26348872338 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 183 (right dACC) | -324.0953143 beta-weight | Standard Deviation 1101.3079494312 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 240 (right vlPFC) | 446.1573213 beta-weight | Standard Deviation 650.27267162975 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Pre-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 281 (right vlPFC) | 220.64673762500 beta-weight | Standard Deviation 609.39673885219 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 29 (left dACC) | -396.4460666 beta-weight | Standard Deviation 779.73833545212 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 183 (right dACC) | -168.76175 beta-weight | Standard Deviation 679.73029181028 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 242 (right vlPFC) | 48.925466799999 beta-weight | Standard Deviation 730.9408131228 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 281 (right vlPFC) | -137.8113024 beta-weight | Standard Deviation 437.9420888 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 240 (right vlPFC) | -287.2243125 beta-weight | Standard Deviation 839.18680962738 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 241 (right vlPFC) | 57.968314699999 beta-weight | Standard Deviation 956.33384050042 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-treatment | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 247 (right AI) | -93.3563077 beta-weight | Standard Deviation 888.06111718986 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 247 (right AI) | -141.689008 beta-weight | Standard Deviation 1181.0573804472 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 242 (right vlPFC) | -264.4217283 beta-weight | Standard Deviation 1149.8191589249 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 241 (right vlPFC) | -482.2452623 beta-weight | Standard Deviation 1373.3034293132 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 183 (right dACC) | 384.62016755555 beta-weight | Standard Deviation 2082.297287103 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 281 (right vlPFC) | -179.9291584 beta-weight | Standard Deviation 1004.2419972306 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 240 (right vlPFC) | -588.4478376 beta-weight | Standard Deviation 1036.4740809912 |
| Discontinued Prior to Randomization | Social Processing (Cyberball) fMRI Task: fMRI Responses | Parcel 29 (left dACC) | 286.13477133333 beta-weight | Standard Deviation 1560.1228270282 |
Other Pre-specified
tDCS Adverse Effects Questionnaire
A questionnaire to evaluate side-effects related to tDCS administration. This questionnaire asks about the presence and severity of possible side-effects of tDCS procedures, and was recently published as a gold-standard tool for this purpose: Aparício LVM, Guarienti F, Razza LB, Carvalho AF, Fregni F, Brunoni AR. A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Brain Stimul. 2016 Oct;9(5):671-81. This is an 11-item scale, that asks about the occurrence and severity of a range of possible side-effects during or after tDCS administration. Each side-effect can be rated as absent, mild, moderate, or severe. Summary data regarding the number of participants who endorsed a listed side-effect from the scale during at least one tDCS administration are presented here. Each participant was asked about the presence and severity of all listed side-effects after each administration of tDCS.
Time frame: Administered after each (12) tDCS session over 6 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Itching | 3 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Burning sensation | 3 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Sleepiness | 3 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Skin Redness | 3 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Headache | 2 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Neck Pain | 0 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Trouble concentrating | 3 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Acute mood change | 0 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Scalp pain | 1 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Other | 1 Participants |
| Sham Anodal tDCS to VLPFC: Pre-treatment | tDCS Adverse Effects Questionnaire | Tingling | 3 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Other | 2 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Neck Pain | 1 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Trouble concentrating | 3 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Itching | 2 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Scalp pain | 1 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Tingling | 2 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Burning sensation | 3 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Skin Redness | 3 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Sleepiness | 2 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Acute mood change | 3 Participants |
| Sham Anodal tDCS to VLPFC: Post-treatment | tDCS Adverse Effects Questionnaire | Headache | 2 Participants |