Altered Neural Pain Empathic Reactivity in NSSI Adolescents | NCT05968313

Studies
Altered Neural Pain Empathic Reactivity in NSSI Adolescents

NCT05968313

Sponsor

University of Electronic Science and Technology of China

Status

Recruiting

Last Update Posted

Apr 11, 2024Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Nonsuicidal Self Injury
Pain Empathy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2023Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Jul 20, 2023

First Submission Date that Met QC Criteria

Jul 20, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2024

Last Update Posted Date

Apr 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Becker, Professor, University of Electronic Science and Technology of ChinaPrincipal Investigator

Lead Sponsor

University of Electronic Science and Technology of ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neural activity as indexed by BOLD fMRI	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Becker	Contact	+86.028-61830867		ben_becker@gmx.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China	Recruiting	Chengdu	Sichuan		China

Condition Browse Module

MeSH Terms

ID	Term
D016728	Self-Injurious Behavior

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided