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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment Feasibility (Number of Participants Enrolled) — From the start of recruitment to completion of enrollment, up to 2 years
  The total number of participants successfully enrolled in this study will be recorded to assess recruitment feasibility. The goal is to recruit 30 participants (15 in each of the two groups) over a 2-year period.
• Intervention adherence (number of participants who completed the full 20 treatment sessions) — End of treatment at Week 4
  This outcome measure will assess participants' adherence to the 20 sessions of transcranial alternating current stimulation. Adherence is defined as completing all 20 sessions. Adherence is calculated by dividing the number of participants who met this criterion by the total number of participants.
• Retention Rate (Number of Participants Remaining at 16-Week Follow-up) — From randomization through the final follow-up assessment at Week 16
  This outcome measure will assess the proportion of participants still enrolled in the study at the 16-week follow-up assessment. Retention rate is calculated as the number of participants who completed the 16-Week assessment divided by the number of participants enrolled at baseline.
• Response rate and remission rate of depressive symptoms — Baseline, throughout the 4-week treatment period, and during follow-up through Week 16
  Preliminary clinical efficacy will be assessed by change in the Children's Depression Rating Scale-Revised (CDRS-R) total score from baseline. CDRS-R is a clinician-rated scale used to assess the severity of depressive symptoms in children and adolescents. It consists of 17 items, and the total score ranges from 17 to 113. Higher scores indicate more severe depressive symptoms. Changes in CDRS-R total score from baseline will be assessed at the end of treatment and at follow-up visits. Response rate of depressive symptoms will be defined as a ≥50% reduction in CDRS-R total score from baseline, and remission rate of depressive symptoms will be defined as a CDRS-R total score ≤28.
• Incidence of Adverse Events and Serious Adverse Events — From the first stimulation session through the final follow-up assessment at Week 16
  Adverse events, abbreviated as AEs, and serious adverse events, abbreviated as SAEs, will be assessed to evaluate the safety and tolerability of the intervention. An AE is defined as any unfavorable medical occurrence in a participant during the study period, regardless of whether it is considered related to the intervention. An SAE is defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is otherwise considered medically significant. The number and proportion of participants experiencing at least one AE or SAE will be recorded throughout the study period. The severity, outcome, and relationship to the intervention will also be documented.

Trial sites (1)

More First Affiliated Hospital of Chongqing Medical University trials in China

Other trials for the same condition