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Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression

Sponsor: First Affiliated Hospital of Chongqing Medical University • ClinicalTrials.gov ID: NCT07185451

Registry updated: 2026-10-05

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Description

This randomized, double-blind, sham-controlled pilot study will evaluate the feasibility, acceptability, safety, and preliminary clinical effects of transcranial alternating current stimulation as an adjunctive treatment for adolescents with major depressive disorder. The study will also explore changes in clinical symptoms, cognitive performance, and brain function following the intervention.

Interventions

tACS (Device)
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 synchronization and modulate brain activity. Participants will undergo daily sessions lasting approximately 40 minutes each, for a total of 20 sessions over 4 weeks. The non-invasive nature of the intervention, combined with its precise targeting of specific brain regions, distinguishes it from other neuromodulation therapies. The treatment aims to enhance neural synchronization, promote neuroplasticity, and provide a non-pharmacological therapeutic alternative for patients.
tACS (Device)
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.

Eligibility criteria

Inclusion Criteria: 1. Age 12-18 years. 2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL. 3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline. 4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study. Exclusion Criteria: 1. Psychiatric comorbidities other than anxiety disorders. 2. Depression with psychotic features. 3. Young Mania Rating Scale (YMRS) score \>13. 4. 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). 5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies. 6. Current use of antiepileptic drugs or high-dose benzodiazepines. 7. History of alcohol or substance abuse or dependence. 8. Pregnant or breastfeeding females. 9. Contraindications to MRI. 10. Current high suicide risk.

Conditions

Depression - Major Depressive Disorder

Locations

The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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