Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04244786

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Device: Transcranial direct current stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: active anodal tDCS to ventrolateral prefrontal cortex (VLPFC) 1.5 milliamp (mA) anodal tDCS over right ventrolateral prefrontal cortex; 20-minutes, 6-sessions	Device: 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.
Sham Comparator: sham anodal tDCS to VLPFC Identical electrode montage, sham tDCS over 6 sessions.	Device: 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.

Arm

Intervention/Treatment

Active Comparator: active anodal tDCS to ventrolateral prefrontal cortex (VLPFC)

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

Device: 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.

Sham Comparator: sham anodal tDCS to VLPFC

Identical electrode montage, sham tDCS over 6 sessions.

Device: 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.

Outcome Measures

Primary Outcome Measures

tDCS Adverse Effects Questionnaire [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.
social processing fMRI task: fMRI responses [One scan each pre- and post-treatment; approx. 10-days apart.]
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 [4-weeks]
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 [One scan each pre- and post-treatment; approx. 10-days apart.]
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 [4-weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.