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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active anodal tDCS to ventrolateral prefrontal cortex (VLPFC) | Active Comparator | 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 |
|
| sham anodal tDCS to VLPFC | Sham Comparator | sham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions. |
|
| Discontinued prior to randomization | Other | Participants who enrolled in the study but discontinued before being randomized to either active or sham arms of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-treatment (baseline) and post-treatment (up to 2 weeks) |
| 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. | One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS) |
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Unstable medical conditions based on medical history or physical examination
Current psychotic disorder, mania, hypomania, intellectual disability
Dermatologic condition resulting in non-intact skin on the scalp
Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient
Pregnancy, currently lactating, or planning to conceive during the course of study participation.
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.
Current alcohol or substance use disorder that is severe according to DSM-V criteria
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
Individuals who initiated psychotherapy within two weeks prior to enrollment
Current seizure disorder.
Use of anticonvulsant medications that target the GABA system (e.g., gabapentin).
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.
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.
Claustrophobia significant enough to interfere with MRI scanning
Weight that exceeds 325 lbs or inability to fit into MRI scanner
Suicide attempt within the past 3 months
Serious self-harm resulting in hospitalization within the past 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M Miller, MD | NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute/Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33884617 | Derived | Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. |
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Scan results, questionnaire answers, and data collected during the task may be used in future studies, and if shared with other investigators, information that identifies the scan, questionnaire responses, or task data with you will be removed before hand.
upon request
upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 29, 2022 |
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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.
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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.
| No intervention | Other | No intervention for participants who discontinued prior to randomization |
|
| Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) |
| 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. | One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS) |
| 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) | pre-treatment (baseline) and post-treatment (up to 2 weeks) |
| 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) | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) |
| 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) | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) |
| Administered after each (12) tDCS session over 6 days |
| FG001 | 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. |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants with non-suicidal self-injurious behavior (at least 2 episodes in the past 2 months) who met study criteria and consented to the study protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Self-reported gender identity | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | 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. | Posted | Mean | Standard Deviation | beta-weight | Pre-treatment (baseline) and post-treatment (up to 2 weeks) |
|
|
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Average score on a scale | One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS) |
| ||||||||||||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Proportion of prompts | One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS) |
| ||||||||||||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | Number of events | pre-treatment (baseline) and post-treatment (up to 2 weeks) |
| ||||||||||||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) |
| ||||||||||||||||||||||||||||||||||||||||
| 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) | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline) |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Administered after each (12) tDCS session over 6 days |
|
For study completers: >4 weeks. Study procedures occur over an approx 4 week period (1 week prior to tDCS procedures, 2 weeks of tDCS procedures, 1 week following tDCS procedures). However, there is generally some time from signing of consent to scheduling of baseline research procedures. In general, time frame is approximately 7-8 weeks for study completers. For individuals who discontinued prior to randomization, time frame is from consent to study discontinuation, generally 1 to 3 weeks.
Possible side-effects during tDCS administration were assessed using a structured instrument, the tDCS Adverse Effects Questionnaire, administered after each tDCS administration. While not all physical experiences endorsed on the scale represent an adverse event, all endorsements from the scale are reported here for thoroughness.
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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 Anodal tDCS to Ventrolateral Prefrontal Cortex (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. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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 | 0 | 7 | 2 | 7 | 0 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment | Medical hospitalization for non-suicidal self-injury that occurred one day after consent, prior to any research procedures beyond evaluation and consent, unrelated to research participation. |
| |
| Suicide Attempt | Psychiatric disorders | Systematic Assessment | Individual crossed the street without looking, indifferent to outcome. No medical injury. Individual did not consider this a suicide attempt, but was categorized as such by our research classification. Occurred prior to randomization. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Scalp Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Burning Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sleepiness | Nervous system disorders | Systematic Assessment |
| ||
| Trouble concentrating | Nervous system disorders | Systematic Assessment |
| ||
| Acute Mood Change | Psychiatric disorders | Systematic Assessment |
| ||
| Other: Heart palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Other: Psychomotor agitation | Psychiatric disorders | Systematic Assessment | Symptom write-in for "other" option. Participant reported feeling "fidgety" |
| |
| Other: Derealization | Psychiatric disorders | Systematic Assessment | Participant wrote in "spacey feeling" for "other" selection |
| |
| Other: Pressure | Product Issues | Systematic Assessment | Participant reported uncomfortable tightness from the headstrap |
|
Small sample size recruited allow for analyses for hypothesis generation and preliminary data supporting future, larger studies.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Miller | New York State Psychiatric Institute | 646-774-7613 | jeffrey.miller@nyspi.columbia.edu |
| Jan 28, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010554 | Personality Disorders |
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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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
Not provided
Not provided
| Male |
|
| Non-Binary |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Parcel 183 (right dACC) |
|
| Parcel 240 (right vlPFC) |
|
| Parcel 241 (right vlPFC) |
|
| Parcel 242 (right vlPFC) |
|
| Parcel 247 (right AI) |
|
| Parcel 281 (right vlPFC) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 |
| Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS |
1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions |
|
|
| Units | Counts |
|---|
| Participants |
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1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions |
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1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions |
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| OG003 | Active Anodal tDCS to Ventrolateral Prefrontal Cortex (VLPFC): Post-tDCS | 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 12 20-minute administrations over 6-sessions |
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