An interventional study of rTMS stimulation of left M1 in NSSI, sponsored by Nanjing Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 10 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
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.
Nanjing Medical University is the lead sponsor of 171 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
4、Pregnant or lactating women; 5、 to magnetic resonance imaging and transcranial magnetic stimulation; 6、Unable or refused to provide written .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exploring the effectiveness of rTMS intervention in NSSI patients using the Ottawa Self Injury Scale and other scales as research subjects
Other: rTMS stimulation of left M1
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.
Other: rTMS stimulation of left M1
This study employed low-frequency repetitive transcranial magnetic stimulation (low-frequency rTMS) targeting the left primary motor cortex (M1 area). The stimulation intensity was set at 110% of the resting motor threshold (RMT). The single-session stimulation protocol was as follows: continuous stimulation at 1 Hz for 60 seconds, followed by a 5-second interval, with this cycle repeated 20 times. Thus, the total number of pulses per session was 1,200. Two sessions were administered daily, with a 40-minute interval between sessions. Treatment was conducted for 5 consecutive days per week, with 2 rest days, for a total of 2 weeks (10 treatment days). Each patient received a total of 24,000 pulses throughout the entire course. Sham stimulation utilized identical stimulation parameters as active stimulation (including frequency, intensity, duration, and number of repetitions), but employed a sham coil. This coil was identical in appearance to the active stimulation coil, producing simila
Ottawa Self-injury Inventory
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.
Time frame: 2 weeks
Magnetic resonance imaging
Time frame: 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for May 2027, 35 months after the start.
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