New York State Psychiatric Institute/Columbia University
New York, 10032, United States
NCT Number: NCT04244786
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
No intervention for participants who discontinued prior to randomization
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
New York State Psychiatric Institute
Other
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