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

Chongqing Medical University

Status: Not yet enrolling

Conditions: Depression - Major Depressive Disorder

Treatments: Device: tACS

Study type: Interventional

Funder types: Other

Identifiers

NCT07185451

1stChongqingMU__ZXY

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

tACS

Experimental group

Description:

Participants in this group will receive transcranial alternating current stimulation (tACS) in addition to their ongoing stable pharmacotherapy. tACS will be delivered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with a frequency of 77.5 Hz and current intensity of 15 mA. One electrode is placed on the forehead and two electrodes on the mastoid processes. Each session lasts approximately 40 minutes, with a total of 20 sessions administered over 4 weeks (5 sessions per week). The intervention aims to modulate cortical activity and improve depressive symptoms, cognitive function, and emotional regulation.

Treatment:

Device: tACS

Device: tACS

Sham

Sham Comparator group

Description:

Participants in this group will receive sham stimulation in addition to their ongoing stable pharmacotherapy. A sham device identical in appearance, sound, and operation to the active tACS device will be used but will not deliver any electrical current. Treatment is administered in the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators are blinded to the treatment assignment to ensure study integrity.

Treatment:

Device: tACS

Device: tACS