Temporal interference stimulation for non‑suicidal self‑injury in adolescent depression
Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression
This trial will test whether temporal interference stimulation (TIS) can reduce non‑suicidal self‑injury in adolescents and young adults (ages 12–22) with major depressive disorder compared with a sham treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 22 Years |
| Sex | All |
| Sponsor | The Second Hospital of Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07554755 on ClinicalTrials.gov |
What this trial studies
This randomized, inpatient study will enroll 60 participants with major depressive disorder and recent non‑suicidal self‑injury to receive either active or sham temporal interference stimulation targeted to the right subgenual anterior cingulate cortex. Treatments are delivered twice daily for 30 minutes over 5–7 days, with clinical ratings collected at baseline, immediately after treatment, and at 2, 4, and 8 weeks follow‑up. Primary and secondary outcomes include NSSI frequency and severity, depressive and anxiety symptom scales (HAMD‑17, HAMA), and measures of suicidal ideation, sleep, somatic symptoms, rumination, impulsivity, and aggression. Safety and tolerability will also be recorded throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are inpatients aged 12–22 with DSM‑5 major depressive disorder, HAMD‑17 score ≥18, recent NSSI (two or more NSSI behaviors in the prior two weeks or NSSI on more than five days in the past year), and who can provide informed consent with a guardian available to monitor them.
Not a fit: Patients with active substance abuse, major comorbid psychiatric or severe neurological/medical conditions, or those who do not meet the specified NSSI or depression severity criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, TIS could reduce self‑injury episodes and improve mood and related symptoms in depressed adolescents.
How similar studies have performed: Temporal interference stimulation has shown promising results for depression in prior work, but its specific effect on non‑suicidal self‑injury is novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder. 2. Patients aged 12-22 years with at least one guardian to monitor them for 3 months 3. HAMD-17 Total score ≥18 4. Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year) 6.Obtain informed consent from patients and guardians \- Exclusion Criteria: 1. Substance abusers such as psychoactive drugs or alcohol. 2. Severe physical disability and unable to complete follow-up. 3. Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc. 4. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime. Unable to read, understand and complete the assessment or to cooperate with the investigators. 5. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS. 6. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline. 7. Other examination abnormalities considered to be inappropriate by investigators. \-
Where this trial is running
Hefei, Anhui
- The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Yanghua Tian, PhD
- Email: tianyh@ahmu.edu.cn
- Phone: +86-13955188448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.