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

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. It will also examine changes in depressive symptoms and related clinical outcomes, while exploring potential effects on emotional regulation, cognitive function, and brain function following the intervention.

ClinicalTrials.gov IDNCT07185451

PhaseNA

Enrollment30

SponsorFirst Affiliated Hospital of Chongqing Medical University

Age12 Years

SexALL

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Conditions studied

Depression - Major Depressive Disorder

About this study

Interventions

Device: 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 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.
Device: 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.

Primary outcomes

Recruitment Feasibility (Number of Participants Enrolled) (From the start of recruitment to completion of enrollment, up to 2 years)
Intervention adherence (number of participants who completed the full 20 treatment sessions) (End of treatment at Week 4)
Retention Rate (Number of Participants Remaining at 16-Week Follow-up) (From randomization through the final follow-up assessment at Week 16)
Response rate and remission rate of depressive symptoms (Baseline, throughout the 4-week treatment period, and during follow-up through Week 16)
Incidence of Adverse Events and Serious Adverse Events (From the first stimulation session through the final follow-up assessment at Week 16)

Eligibility information

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.

Study locations

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality 40000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.