Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) in Adolescents With First-episode Depression Who Are Drug-naive: A Randomized, Double-blind, Controlled Pilot Study

NCT07185464 | Not Yet Recruiting DMC

• 1 other identifier: 1stChongqingMU___ZXY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

  Clinical response (≥ 50% reduction in CDRS-R scores from baseline)

  Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.

Secondary Outcomes (8)

• Change in BDI-II (Baker Depression Scale) scores from baseline

  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

  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)

  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

  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

  Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.

Study Arms (2)

tACS

EXPERIMENTAL

Participants in this group will receive transcranial alternating current stimulation (tACS) in addition to daily oral sertraline. tACS will be administered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with stimulation parameters set at a frequency of 77.5 Hz and a current intensity of 15 mA. One electrode will be placed on the forehead and two electrodes on the mastoid processes. Each session will last approximately 40 minutes, with a total of 20 sessions delivered across 4 consecutive weeks (5 sessions per week). The intervention is designed to modulate abnormal cortical oscillations, thereby alleviating depressive symptoms, enhancing cognitive performance, and supporting emotional regulation.

Device: tACS

Sham

SHAM COMPARATOR

Arm Description: Participants in this group will receive sham stimulation in addition to daily oral sertraline. A sham device, identical in appearance, sound, and operation to the active tACS device, will be used but will not deliver any electrical current. Sessions will follow the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators will remain blinded to treatment allocation to maintain trial integrity.

Device: tACS

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-18 years; 2.Subjects met the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as determined by the Childhood Affective Disorders and Schizophrenia Questionnaire (K-SADS-PL) and were currently in a depressive episode; 3.Children's Depression Rating Scale-Revised (CDRS-R) score ≥ 40 points; 4.Not receiving any antidepressant medication during the current depressive episode.

You may not qualify if:

• Other comorbid mental disorders in accordance with DSM-5 except anxiety disorders; 2.Depression with psychotic symptoms; 3.Young Mania Rating Scale (YMRS) \> 13; 4.History of neurological disease (such as epilepsy, brain trauma, etc.) or serious physical disease (such as thyroid disease, lupus erythematosus, diabetes, lung, liver and kidney damage, major trauma, etc.); 5.Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS or other neurostimulation treatments; 6.Patients currently receiving anti-epileptic drugs or high-dose benzodiazepines; 7.History of alcohol or drug abuse or dependence; 8.Breastfeeding women or pregnant women; 9.Contraindications to MRI; 10.Currently at high risk of suicide.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 40000, China

Location

Related Publications (14)

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Central Study Contacts

Xinyu Zhou

CONTACT

15823996993; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: This study adopts a parallel assignment design. Participants will be randomized in a 1:1 ratio to either the active tACS group or the sham stimulation group, with all participants receiving oral sertraline throughout the trial. The intervention group will undergo 20 sessions of active tACS over 4 weeks, while the control group will receive sham stimulation using an identical device that delivers no current. Participants will remain in their assigned group for the entire duration of the study without crossover.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CN (1)