Active Temporal Interference Stimulation (TIS)Sham Temporal Interference Stimulation (TIS)
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.
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.
Study 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
Sex
ALL
Min age
12 Years
Max age
22 Years
Healthy volunteers
No
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
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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.
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Primary outcome measure(s)
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 Containing one subscale evaluating the frequency and primary methods of self-injury behaviors in patients over the past 2 weeks,and one subscale ranging from 0 to 10 to assess the self-injurious thoughts, with 0 indicating "not at all" and 10 indicating "very strongly."
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 Range from 0-52, higher score indicates more severe symptoms
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
More The Second Hospital of Anhui Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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