RecruitingNot ApplicableNCT07554755

TIS for NSSI in Adolescent Depression

Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression


Sponsor

The Second Hospital of Anhui Medical University

Enrollment

60 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 12 YearsMax Age: 22 Years

Inclusion Criteria6

  • Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
  • Patients aged 12-22 years with at least one guardian to monitor them for 3 months
  • HAMD-17 Total score ≥18
  • 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)
  • Obtain informed consent from patients and guardians
  • \-

Exclusion Criteria9

  • Substance abusers such as psychoactive drugs or alcohol.
  • Severe physical disability and unable to complete follow-up.
  • 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.
  • 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.
  • Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS.
  • Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
  • Other examination abnormalities considered to be inappropriate by investigators.
  • \-

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Interventions

DEVICEActive 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.

DEVICESham 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.


Locations(1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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NCT07554755


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