Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT07185451
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.
Detailed 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.
Study:
NCT07185451
Study Brief:
Protocol Section:
NCT07185451