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Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Primary Purpose

Self-Injurious Behavior, Self Harm, Self-injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Self-Injurious Behavior focused on measuring Transcranial direct current stimulation, Transcranial electric stimulation, non-invasive brain stimulation, tDCS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 a therapeutic dose of a mood stabilizer.
Normal hearing.
Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -

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 moderate or severe
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
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
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.
-

Sites / Locations

New York State Psychiatric Institute/Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active anodal tDCS to ventrolateral prefrontal cortex (VLPFC)

sham anodal tDCS to VLPFC

Arm Description

1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 20-minutes, 6-sessions

Identical electrode montage, sham tDCS over 6 sessions.

Outcomes

Primary Outcome Measures

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.

social processing fMRI task: fMRI responses

Pre- and post-treatment fMRI scan to assess changes in brain responses during a social processing task following the tDCS intervention

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 will be prompted to complete a brief questionnaire 6 times per day over a 3 week period, which asks questions about urges to engage in NSSI and in actual NSSI behavior.

Secondary Outcome Measures

social processing fMRI task: emotional responses

Ratings of affect (mood state) will be measured a total of 5 times during each social processing fMRI task, which will be performed before and after a course of tDCS.

Ecological Momentary Assessment (EMA): affect ratings

Assessment of daily changes in affect during and after tDCS intervention. Participants will be prompted to complete a brief questionnaire 6 times per day as described in Outcome 2. This questionnaire will also ask questions about mood/affect.

Full Information

NCT ID

NCT04244786

First Posted

October 23, 2019

Last Updated

July 28, 2023

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT04244786

Brief Title

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Official Title

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

July 29, 2022 (Actual)

Study Completion Date

July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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). 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 at-home, self-administered 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 days over approximately two weeks. Participants will be trained on tDCS self-administration, which will be supervised during each session over a videoconferencing platform by a researcher. Functional MRI (fMRI) may be performed at baseline and again after the completion of 12 sessions 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

active anodal tDCS to ventrolateral prefrontal cortex (VLPFC)

Arm Type

Active Comparator

Arm Description

1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 20-minutes, 6-sessions

Arm Title

sham anodal tDCS to VLPFC

Arm Type

Sham Comparator

Arm Description

Identical electrode montage, sham tDCS over 6 sessions.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

tDCS Adverse Effects Questionnaire

Description

Time Frame

Administered after each (12) tDCS session over 6 days

Title

social processing fMRI task: fMRI responses

Description

Pre- and post-treatment fMRI scan to assess changes in brain responses during a social processing task following the tDCS intervention

Time Frame

One scan each pre- and post-treatment; approx. 10-days apart.

Title

Ecological Momentary Assessment (EMA): NSSI urges and behavior

Description

Time Frame

4-weeks

Secondary Outcome Measure Information:

Title

social processing fMRI task: emotional responses

Description

Ratings of affect (mood state) will be measured a total of 5 times during each social processing fMRI task, which will be performed before and after a course of tDCS.

Time Frame

One scan each pre- and post-treatment; approx. 10-days apart.

Title

Ecological Momentary Assessment (EMA): affect ratings

Description

Time Frame

4-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 a therapeutic dose of a mood stabilizer. Normal hearing. Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. - 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 moderate or severe 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 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 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey M Miller, MD

Organizational Affiliation

NYSPI

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York State Psychiatric Institute/Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

33884617

Citation

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.

Results Reference

derived

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Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

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