Clinical trial NCT06540300: Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury
Official title: Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: NSSI
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study used a randomized, double-blind study method that controlled true and false stimuli. Except for the study leader, neither the actual operators nor the patients themselves knew whether they were receiving real or fake stimuli.

A two factor mixed trial design was adopted, with a detection time of 2 (pre stimulus vs post stimulus) x 2 (stimulus type: right IPL vs pseudo stimulus). The stimulus type was an inter subject factor, and the detection time was an intra subject factor.

The enrolled NSSI patients were randomly divided into a study group (right IPL group) and a control group (pseudo stimulus group) using a random number table method. Collect general demographic scales, symptom scales, and magnetic resonance imaging data before treatment, and conduct symptom scale retesting and magnetic resonance imaging data collection 2 weeks after treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Possible Benefits All clinical scale evaluations, imaging examinations, and repeated transcranial magnetic stimulation interventions related to the study are free of charge. Your research doctors and evaluators will conduct timely clinical observations of changes in your condition, and provide you with systematic research follow-up and evaluation. These evaluations will help make reasonable judgments about your disease status and treatment effectiveness, and thus guide treatment decisions more scientifically. In addition, free treatment with repeated transcranial magnetic stimulation is also beneficial for the improvement of your condition. The research team will coordinate with relevant staff in the hospital and department where you are seeking medical treatment to provide convenience in basic clinical services such as doctor appointments, registration, and waiting, in order to save your visit time.

Privacy and Confidentiality Issues If you decide to participate in this study, your participation in the experiment and your personal information during the experiment will be kept confidential. Responsible research doctors and other researchers will use your medical information for research, but will not disclose your personal information. If you are harmed by participating in this study, you can receive free treatment and/or corresponding compensation.

Eligibility criteria: Inclusion Criteria:

1. Meets the NSSI diagnostic criteria recommended in DSM-5;
2. The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screen for diagnostic compliance;
3. Age :10-55 years old;
4. Right hand;
5. The paitent voluntarily participate and sign the informed consent form for this study (signed by participants under the age of 18 and their families);
6. Able to understand written language and cooperate with questionnaire surveys.

Exclusion Criteria:

1. History of severe substance abuse;
2. 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.

Primary outcomes:
measure: Ottawa Self-injury Inventory
timeFrame: 2 weeks
measure: Magnetic resonance imaging
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
References: