静息态功能连接MRI引导的rTMS治疗青少年重性抑郁障碍：随机双盲三臂假对照预试验方案
Feasibility, safety, and preliminary clinical efficacy of resting-state functional connectivity MRI-guided rTMS for adolescents with major depressive disorder: Protocol for a randomized, double-blind, three-arm, sham-controlled pilot trial
青少年重性抑郁障碍对一线药物和心理治疗反应常不充分，rTMS（重复经颅磁刺激）在成人有效但青少年证据有限。该研究将45名青少年随机分入三组：常规左侧DLPFC（背外侧前额叶）靶点rTMS、依据静息态功能连接MRI（测量脑区之间协同活动）个体化选择的靶点rTMS、以及假刺激，治疗4周。主要观察招募可行性、依从性、6个月留存、初步疗效与安全性。这是研究方案，尚无结果，旨在为未来大型确证性试验铺路。
为什么推荐给您：仅为研究方案，个体化影像引导rTMS思路有价值，但尚无结果，属常规增量
不需要生物学背景，多打比方
正在获取全文并生成讲解（拿不到全文就依据摘要），大约需要 30–60 秒…
已等待 0 秒
这篇还没有动画
动画会把研究的流程、作用机制和关键结果一步一步演示出来，每一步都标明出自原文哪里。制作大约需要 30–60 秒。
摘要Abstract
BACKGROUND: Major depressive disorder (MDD) is highly prevalent in adolescents, and a substantial proportion of patients show inadequate response or limited tolerability to first-line treatments such as selective serotonin reuptake inhibitors and cognitive behavioral therapy, highlighting the need for additional treatment options. Repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in adults with depression, but evidence in adolescents remains limited. Resting-state functional connectivity MRI (rs-fcMRI) may provide a circuit-informed approach for individualizing rTMS target selection within the dorsolateral prefrontal cortex (DLPFC) based on its functional connectivity with the subgenual anterior cingulate cortex (sgACC).
METHODS: This is a randomized, double-blind, three-arm, sham-controlled pilot trial. Forty-five adolescents with MDD will be assigned in a 1:1:1 ratio to conventional left DLPFC-targeted rTMS, rs-fcMRI-guided rTMS targeting the individualized DLPFC site showing the strongest negative connectivity with the sgACC, or sham stimulation. Treatment will be delivered over 4 weeks. Primary outcomes will include recruitment feasibility, intervention adherence, 6-month retention, preliminary clinical efficacy, and safety, assessed by enrollment, completion of 20 treatment sessions, completion of 6-month follow-up, CDRS-R-based response and remission, and adverse events/serious adverse events. Secondary outcomes will include depressive and anxiety symptoms, suicidality, sleep quality, global clinical status and improvement, rumination, and pediatric health-related quality of life.
DISCUSSION: This pilot trial will provide preliminary evidence regarding the feasibility, acceptability, safety, and early clinical efficacy signals of rs-fcMRI-guided rTMS in adolescents with MDD. By comparing individualized circuit-informed targeting with conventional left DLPFC stimulation and sham stimulation, the study may help clarify whether this imaging-guided neuromodulation approach is practicable and clinically informative in this population. The findings are expected to support refinement of study procedures, outcome selection, and trial design for a future fully powered randomized controlled trial. Trial registration: ClinicalTrials.gov NCT07185438.