- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04244786
Treating Self Injurious Behavior: A Novel Brain Stimulation Approach
July 28, 2023 updated by: Jeffrey Miller, New York State Psychiatric Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute/Columbia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tDCS Adverse Effects Questionnaire
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.
|
Administered after each (12) tDCS session over 6 days
|
social processing fMRI task: fMRI responses
Time Frame: 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
|
One scan each pre- and post-treatment; approx. 10-days apart.
|
Ecological Momentary Assessment (EMA): NSSI urges and behavior
Time Frame: 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.
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4-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
social processing fMRI task: emotional responses
Time Frame: 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.
|
One scan each pre- and post-treatment; approx. 10-days apart.
|
Ecological Momentary Assessment (EMA): affect ratings
Time Frame: 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.
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4-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey M Miller, MD, NYSPI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
July 29, 2022
Study Completion (Actual)
July 29, 2022
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
January 24, 2020
First Posted (Actual)
January 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
July 28, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #7170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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