Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ottawa Self-injury Inventory
研究概览
简要总结
Non-suicidal self-injury (NSSI) refers to a series of direct and consequently repeated injuries to one's body without suicidal intent. At present, it has become an important issue of mental disorders. This article focuses on the formation mechanism of NSSI and the intervention effect of rTMS on NSSI patients. At the same time, NSSI patients are collected, a treatment plan is designed to complete a two-week treatment, and the results are analyzed. The aim is to provide theoretical basis for the clinical diagnosis and treatment of NSSI, and also to provide reference for the clinical diagnosis and treatment of NSSI patients.
详细描述
Research Objective Non suicidal self injury (NSSI) behavior is a common behavioral issue in psychiatric and psychiatric clinics. Studies have shown that NSSI is on the rise in China and has become an important mental health issue. Non suicidal self injury and suicide have similar clinical manifestations. Therefore, this study will intervene in the treatment of NSSI patients, understand the occurrence of NSSI in psychiatric outpatient and inpatient wards, and observe the efficacy of repeated transcranial magnetic stimulation intervention in NSSI patients, in order to explore the current occurrence status and biopsychological etiology of NSSI in psychiatric clinical practice.
Research Process If you agree to participate in this study, please read and sign this informed consent form before participating in any of the following procedures.
Research location: All research processes and evaluation interviews were conducted at the Affiliated Brain Hospital of Nanjing Medical University.
Study participants: Participants clinically diagnosed with non suicidal self injury participated in this study, aged 10-60 years, regardless of gender. All participants entered the study after signing the informed consent form.
Research Procedures This study first clarifies your diagnosis by conducting interviews to understand your physical health status, course of illness, family history, previous medical treatment, and examination results. We will assign a number to each participant, establish a medical record, and then perform corresponding psychological assessments, magnetic resonance imaging examinations, and repeat transcranial magnetic stimulation therapy for two weeks (a total of 10 times).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the NSSI diagnostic criteria recommended in DSM-5;
- •The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screen for diagnostic compliance;
- •Age :10-55 years old;
- •Right hand;
- •The paitent voluntarily participate and sign the informed consent form for this study (signed by participants under the age of 18 and their families);
- •Able to understand written language and cooperate with questionnaire surveys.
排除标准
- •History of severe substance abuse;
- •The patient has other serious mental disorders, neurological disorders, or physical illnesses; 3、Previously experienced epileptic seizures;
- •4、Pregnant or lactating women; 5、Contraindications to magnetic resonance imaging and transcranial magnetic stimulation; 6、Unable or refused to provide written informed consent.
研究组 & 干预措施
Effects of rTMS on NSSI
Exploring the effectiveness of rTMS intervention in NSSI patients using the Ottawa Self Injury Scale and other scales as research subjects
干预措施: rTMS stimulation of left M1 (Other)
rs-fMRI-functional connectivity
Based on rs fMRI technology, imaging methods were used to analyze the brain images of patients and explore the changes in functional connectivity of brain regions before and after intervention in two groups of subjects.
干预措施: rTMS stimulation of left M1 (Other)
结局指标
主要结局
Ottawa Self-injury Inventory
时间窗: 2 weeks
OSI was evaluated by professionally trained doctors (non experimental intervention) at baseline and two weeks after treatment to assess the effectiveness of the treatment. Comparing the differences in self harm thoughts and behaviors between the baseline period and the intervention group and the control group, p\<0.05 indicates a significant difference.
Magnetic resonance imaging
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Chun Wang
Associate chief physician
Nanjing Medical University