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RECRUITING
NCT07185451
NA

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

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-10-01

Completion Date

2027-10-01

Last Updated

2026-08-17

Healthy Volunteers

No

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.

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China