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Efficacy and Safety of Transcranial Alternating Current Stimulation in the Treatment of Adolescent Depression with Non-suicidal Self-injury Behavior: A Randomized Double-blind Controlled Study

Efficacy and Safety of Transcranial Alternating Current Stimulation in the Treatment of Adolescent Depression with Non-suicidal Self-injury Behavior: A Randomized Double-blind Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118169
Enrollment
Unknown
Registered
2026-02-03
Start date
2024-11-05
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Adolescent depression with non-suicidal self-injury

Interventions

Treatment Group:Transcranial alternating current stimulation (tACS) was administered.During the electrical stimulation procedure, the electrode positions were determined and located using the internat
Control Group:The control group was treated with a sham stimulator. The sham stimulator did not deliver electric current and thus exerted no stimulation on the cerebral cortex. Except for the absence

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for depression in the DSM-IV; 2. Being of Han ethnicity and right-handed; 3. Aged 13–17 years with at least 6 years of education; 4. Having no exposure to antidepressant medications in the 4 weeks prior to enrollment, or having been on a stable dose of antidepressants for more than 4 weeks; 5. Achieving a total score of >= 20 on the HAMD-24; and testing positive on the Ottawa Self-Injury Scale; 6. Having normal visual acuity, either uncorrected or corrected with glasses; 7. Having the informed consent form signed by the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: 1. A history of severe somatic or organic brain diseases and a history of craniocerebral trauma; 2. A history of attempted suicide within 1 year prior to screening; or a score of >= 3 on Item 3 (suicide item) of the HAMD-24; 3. Receipt of physical therapies such as electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 1 month; 4. Changes in medication dosage during the treatment course; 5. A history of substance abuse involving drugs, alcohol, or other psychoactive substances; 6. Having implanted metal devices in the body, such as a cardiac pacemaker; 7. Secondary anxiety caused by other organic diseases; 8. Other circumstances deemed inappropriate for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Assess behaviors related to non-suicidal self-injury, suicidal ideation and the degree of addiction;the severity of depressive symptoms and the improvement after treatment;the severity of anxiety symptoms and the efficacy of interventions;sleep quality and post-treatment sleep improvement;Spontaneous brain activity and functional connectivity among brain networks;immune-inflammatory factors and stimulation-related specific immune markers;

Countries

China

Contacts

Public ContactWang Yuping

The First Hospital of Hebei Medical University

wangyuping01@sina.cn+86 135 0118 6298

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026