NSSINCT06540300
Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury
A study testing rTMS stimulation of left M1 in people with NSSI, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 55 years
- Conditions the study is for
- NSSI
- What is being tested?
- rTMS stimulation of left M1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- NSSI
- Being tested
- rTMS stimulation of left M1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS stimulation of left M1Other
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
| Study group | Role | What they receive |
|---|---|---|
| Effects of rTMS on NSSI | Experimental | Exploring the effectiveness of rTMS intervention in NSSI patients using the Ottawa Self Injury Scale and other scales as research subjects Receives: Other: rTMS stimulation of left M1 |
| rs-fMRI-functional connectivity | Experimental | 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. Receives: Other: rTMS stimulation of left M1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Magnetic resonance imaging
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start30 Jun 2024
- Primary completion30 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSSIStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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: left M1 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 (left M1 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Wang, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540300
- Sponsor's protocol ID
- 2023-KY035-01
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury
- ClinicalTrials.gov ID
- NCT06540300
- Acronym / sponsor ID
- 2023-KY035-01
- Conditions
- NSSI
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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: left M1 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 (left M1 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.
| Arm | Type | Receives |
|---|---|---|
| Effects of rTMS on NSSI | Experimental | Other: rTMS stimulation of left M1Exploring the effectiveness of rTMS intervention in NSSI patients using the Ottawa Self Injury Scale and other scales as research subjects |
| rs-fMRI-functional connectivity | Experimental | Other: rTMS stimulation of left M1Based 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. |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS stimulation of left M1This 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 | Other | Effects of rTMS on NSSI, rs-fMRI-functional connectivity |
Primary outcome
Ottawa Self-injury Inventory
Time frame: 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
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS stimulation of left M1 in people with NSSI, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ottawa Self-injury Inventory (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.