Skip to content

Bilateral Repetitive Transcranial Magnetic Stimulation for Emotion Regulation in Adolescents with Non-Suicidal Self-Injury: A Randomized Controlled Exploratory Clinical Trial

Bilateral Repetitive Transcranial Magnetic Stimulation for Emotion Regulation in Adolescents with Non-Suicidal Self-Injury: A Randomized Controlled Exploratory Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123081
Enrollment
Unknown
Registered
2026-04-21
Start date
2025-02-17
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent emotional disorders with non-suicidal self-injury

Interventions

Active rTMS + Medication Group :Received rTMS combined with routine pharmacotherapy. rTMS was delivered using a sequential bilateral DLPFC protocol: high frequency stimulation over the left DLPFC (10
Sham rTMS + Medication Group:Received sham rTMS combined with routine pharmacotherapy. The procedure, coil placement, treatment duration and frequency were identical to the active rTMS group, but a pl
Medication Only Group:Received no rTMS intervention, only standardized pharmacotherapy and routine clinical follow?up.

Sponsors

The Third Hospital of Jinjiang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 12–18 years, with no gender restriction; 2. Meet the diagnostic criteria for Non-Suicidal Self-Injury (NSSI) in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), with at least one definite NSSI episode in the past 3 months without suicidal intent; 3. Total score of the Difficulties in Emotion Regulation Scale (DERS) is higher than the cutoff value of the Chinese adolescent norm, indicating significant emotion regulation difficulties; 4. Medication status: - For participants already taking psychotropic medications before enrollment, a stable dosage for >=4 weeks is required, with no changes in medication type or dosage during the study to avoid confounding effects on outcomes; - For medication-naïve participants, routine pharmacotherapy will be initiated by clinicians according to the Chinese Guidelines for the Prevention and Treatment of Depressive Disorders (2025 Edition), with Selective Serotonin Reuptake Inhibitors (SSRIs) as the first-line agents; 5. Participants possess basic ability to understand and cooperate; their legal guardians have been fully informed of the study purpose, procedures, potential benefits and risks, and have voluntarily provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of epilepsy, organic brain disease (e.g., traumatic brain injury, cerebrovascular disease, brain tumor, etc.), or epileptiform discharges on electroencephalogram (EEG), representing contraindications for rTMS treatment; 2. Presence of metallic implants (e.g., skull pins, cardiac stents, etc.), electronic implantable devices (e.g., cardiac pacemakers, deep brain stimulators, etc.), open wounds on the head, or severe dermatological conditions; 3. Previous treatment with rTMS, electroconvulsive therapy (ECT), transcranial direct current stimulation (tDCS), or other neuromodulation therapies; 4. High suicide risk assessed by the Columbia Suicide Severity Rating Scale (C-SSRS); 5. Comorbid severe physical diseases (e.g., severe cardiac, hepatic, or renal insufficiency), substance abuse/dependence, or unstable psychiatric symptoms including manic episodes or psychotic symptoms, resulting in inability to comply with study procedures; 6. Unable to provide valid informed consent, or expected poor adherence to study follow-up and operational procedures with high risk of dropout.

Design outcomes

Primary

MeasureTime frame
Difficulties in Emotion Regulation Scale-16-item version, DERS-16;Columbia-Suicide Severity Rating Scale (C-SSRS) - Self-Injury Items;

Secondary

MeasureTime frame
Barratt Impulsiveness Scale-11-item version, BIS-11;Hamilton Anxiety Rating Scale-17-item version, HAMA-17;Hamilton Depression Rating Scale-24-item version, HAMD-24;Event-related potential data;

Countries

China

Contacts

Public ContactZheng Jiaren

The Third Hospital of Jinjiang,Fujian,China

150482573@qq.com+86 159 6057 8990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026