search
Back to results

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
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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 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 moderate or severe
  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. 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.
  11. Claustrophobia significant enough to interfere with MRI scanning
  12. Weight that exceeds 325 lbs or inability to fit into MRI scanner
  13. Current seizure disorder.
  14. Use of anticonvulsant medications that target the GABA system (e.g., gabapentin).
  15. 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

First Posted
October 23, 2019
Last Updated
July 28, 2023
Sponsor
New York State Psychiatric Institute
search

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
No
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
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.
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
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.
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
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.
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
No
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

Learn more about this trial

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

We'll reach out to this number within 24 hrs