- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05968313
Altered Neural Pain Empathic Reactivity in NSSI Adolescents
April 9, 2024 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Abnormal Neural Pain Empathic Processing in Adolescents With Non-suicidal Self-Injury
Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention.
In recent years, growing evidence suggests that NSSI has become a worldwide public health issue.
People with NSSI behaviors, especially adolescents, commonly exhibit emotion-related and interpersonal problems.
Pain empathy represents an essential basal domain of socio-emotional processing and refers to the ability to empathize, connect and share with others' pain.
However, altered empathic processing has not been systematically examined in adolescents with NSSI.
To this end, the current functional magnetic resonance imaging (fMRI) study will recruit one group of NSSI adolescents (n=40) and one healthy control (HC) group (n=40), to compare their neural activity regarding pain empathy processing, which is measured by blood oxygenation level-dependent (BOLD) fMRI.
The investigators included conditions of physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli.
The investigators hypothesize that compared to HC, NSSI adolescents show increased empathic reactivity to physical pain stimuli in salience and arousal related brain regions but decreased empathic reactivity to affective pain empathic stimuli.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Becker
- Phone Number: +86.028-61830867
- Email: ben_becker@gmx.de
Study Locations
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Sichuan
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Chengdu, Sichuan, China
- Recruiting
- Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China
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Contact:
- Lyuan Li
- Email: lly_psychology@163.com
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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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community
Description
Inclusion Criteria:
- 15-18 years
- right-handed
- normal or corrected normal visual acuity
- meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)
Exclusion Criteria:
- diagnosis of borderline personality disorder, major depressive disorder, other
- psychiatric disorders, etc.
- high suicidal risk
- recent use of medications that can affect neural activity
- have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
- have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
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
Cohorts and Interventions
Group / Cohort |
|---|
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NSSI
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HC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural activity as indexed by BOLD fMRI
Time Frame: About 8 minutes
|
Brain activity will be monitored by task-based fMRI.
The paradigm will present affective and physical pain empathy pictures and matched control stimuli.
Alterations in the patients will be determined by comparing neural activity to the experimental conditions between the experimental groups (NSSI vs. HC) using ANOVA models.
|
About 8 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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)
December 6, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
July 20, 2023
First Submitted That Met QC Criteria
July 20, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAM_lab_NSSI_02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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