Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study

Обзор

To evaluate the efficacy of tACS treatment. To determine whether tACS can accelerate symptom remission, improve clinical response rates, and facilitate the recovery of emotional and cognitive functions through standardized clinical assessments. To evaluate the safety of tACS treatment. To assess adverse events and side effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.

Подробное описание

This randomized, double-blind, sham-controlled pilot trial will evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) combined with stable pharmacotherapy in adolescents with major depressive disorder (MDD). Eligible participants are aged ≥8 years, meet DSM-5 criteria for a current depressive episode, have a CDRS-R score ≥40, and have been on stable antidepressant treatment for at least 4 weeks.

A total of 30 participants will be randomized 1:1 to receive either active tACS or sham stimulation, in addition to their ongoing medication. The active group will undergo 20 sessions over 4 weeks (5 sessions per week) using the NEXALIN ADI device (77.5 Hz, 15 mA, \~40 minutes per session). The sham device is identical in appearance but delivers no current. Both participants and operators will remain blinded.

The primary outcomes are changes in depressive symptoms measured by the CDRS-R and BDI. Secondary outcomes include anxiety (SCARED, HAMA), global improvement (CGI-S, CGI-I), suicide risk (C-SSRS), quality of life (PedsQL), sleep (PSQI), rumination (RRS), and cognition (THINC-it). Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments.

This pilot study will provide preliminary evidence on the potential of tACS as an adjunctive treatment for adolescent depression and inform future large-scale trials.

Вмешательства

• Устройство tACS
  This intervention uses the NEXALIN ADI alternating current stimulation device from Beijing Naisilin Technology Co., Ltd., to deliver targeted stimulation to the prefrontal cortex and bilateral mastoid regions. The prefrontal cortex electrode directly stimulates the cerebral cortex, while the mastoid electrodes ensure the synchronized activation of bilateral neural pathways. Stimulation is applied at a frequency of 77.5 Hz and a current intensity of 15 mA, aiming to optimize brainwave synchroniza
• Устройство tACS
  In the sham stimulation group, participants will receive intervention using a sham device that is identical in appearance, operation, and stimulation protocol to the real tACS device, but does not deliver any current. Both participants and operators will be unable to distinguish between real and sham stimulation based on the device's appearance, sound, or tactile feedback. Device allocation will follow a randomized code generated in advance to ensure blinding and proper group assignment.

Первичные конечные точки

• Change in CDRS-R (Children's Depression Rating Scale) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months]

Вторичные конечные точки (8)

• Change in BDI-II (Baker Depression Scale) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale) [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months]
• Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months]
• Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months]
• Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months]
• Change in RSS (Ruminative Responses Scale) [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months]

Критерии участия

Критерии включения

• Age 12-18 years.
• Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.
• Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.
• Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.

Критерии исключения

• Psychiatric comorbidities other than anxiety disorders.
• Depression with psychotic features.
• Young Mania Rating Scale (YMRS) score >13.
• History of neurological disorders (e.g., epilepsy, traumatic brain injury) or severe physical illnesses (e.g., thyroid disease, lupus, diabetes, significant liver, kidney, or lung impairment, major trauma).
• Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.
• Current use of antiepileptic drugs or high-dose benzodiazepines.
• History of alcohol or substance abuse or dependence.
• Pregnant or breastfeeding females.
• Contraindications to MRI.
• Current high suicide risk.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Публикации

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Идентификаторы

NCT: NCT07185451 · 1stChongqingMU__ZXY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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