Effects of Repetitive Transcrannial Magnetic Stimulation on Non-Suicidal Self-Injury

NCT06540300 | Enrolling By Invitation

• 1 other identifier: 2023-KY035-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

NSSI

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• Magnetic resonance imaging

  2 weeks

Study Arms (2)

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

Other: rTMS stimulation of right IPL

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.

Other: rTMS stimulation of right IPL

Interventions

rTMS stimulation of right IPL OTHER

The stimulation site is the right IPL (EEG International 10-20 system, electrode CP4/CP6), with a stimulation frequency of 1-Hz and intensity of 100% RMT. There are 50 pulses each time, 20 seconds each cycle, 5 seconds each, with an interval of 15 seconds, for a total of 60 cycles, a total duration of 20 minutes, and a total of 3000 pulses. Perform treatment once a day, rest for 2 days after 5 consecutive days of treatment, for a total of 2 weeks, and receive 10 treatments.

Effects of rTMS on NSSI; rs-fMRI-functional connectivity

Eligibility Criteria

• Age: 10 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of severe substance abuse;
• The patient has other serious mental disorders, neurological disorders, or physical illnesses; 3、Previously experienced epileptic seizures;
• 、Pregnant or lactating women; 5、Contraindications to magnetic resonance imaging and transcranial magnetic stimulation; 6、Unable or refused to provide written informed consent.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 6, 2024
• Study Start: June 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 15, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)