Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

NCT04244786 | Completed Results FDA Device

• 1 other identifier: #7170
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-Injurious Behavior; Self Harm; Self-injury; Self-inflicted Injury; Self Injurious Behavior Without Suicidal Intent; Non-Suicidal Self Injury; Non Suicidal Self Inflicted Injury; Cutting; Depression; Bipolar Disorder; Borderline Personality Disorder

Keywords

Transcranial direct current stimulation; Transcranial electric stimulation; non-invasive brain stimulation; tDCS

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

Other Outcomes (1)

• tDCS Adverse Effects Questionnaire

  Administered after each (12) tDCS session over 6 days

Study Arms (3)

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

Device: Transcranial direct current stimulation

sham anodal tDCS to VLPFC

SHAM COMPARATOR

sham anodal tDCS to VLPFC Identical electrode montage, 12 administrations of sham tDCS over 6 sessions.

Device: Transcranial direct current stimulation

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

Other: No intervention

Interventions

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.

active anodal tDCS to ventrolateral prefrontal cortex (VLPFC); sham anodal tDCS to VLPFC

No intervention OTHER

No intervention for participants who discontinued prior to randomization

Discontinued prior to randomization

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• 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
• Capacity to provide informed consent
• If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
• Normal hearing.
• Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute/Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Depression; Bipolar Disorder; Borderline Personality Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Personality Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Small sample size recruited allow for analyses for hypothesis generation and preliminary data supporting future, larger studies.

Results Point of Contact

• Title: Jeffrey Miller
• Organization: New York State Psychiatric Institute

jeffrey.miller@nyspi.columbia.edu

646-774-7613

Study Officials

• Jeffrey M Miller, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: January 28, 2020
• Study Start: October 1, 2019
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: upon request
• Access Criteria: upon request

Locations

US (1)