Recruiting

TIS for NSSI in Adolescent Depression

Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).

ClinicalTrials.gov IDNCT07554755

PhaseNA

Enrollment60

SponsorThe Second Hospital of Anhui Medical University

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Temporal Interference Stimulation, Non Suicidal Self Injury, Major Depressive Disorder

About this study

Interventions

Device: Active Temporal Interference Stimulation (TIS) — Active stimulation to the right subgenual anterior cingulate cortex; 2 sessions per day, 30 minutes per session, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end, for 5-7 days.
Device: Sham Temporal Interference Stimulation (TIS) — Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.

Primary outcomes

Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ) (Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS)
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17) (Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS)

Eligibility information

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. \-

Study locations

The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.