功能磁共振成像引导下的个体化重复经颅磁刺激（fMRI-rTMS）治疗情感迟钝型抑郁症患者的疗效：一项随机对照试验的研究方案。

Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial.

机构信息

Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, Xi'an, China.

Department of Psychiatry, the 907th Hospital of the PLA Joint Logistics Support Force, Nanping, Fujian, China.

出版信息

Trials. 2024 Feb 21;25(1):134. doi: 10.1186/s13063-024-07976-3.

DOI:10.1186/s13063-024-07976-3

PMID:38383418

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10880253/

Abstract

BACKGROUND

Emotional blunting is a symptom that has always been present in depressed patients. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective supplementary therapy for treating depression. However, the effectiveness and brain imaging processes of functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) in the treatment of depression with emotional blunting have not been observed in randomized controlled trials.

METHODS

This study is a randomized, controlled, double-blind, and single-center clinical trial in which 80 eligible depressed patients with emotional blunting will be randomly assigned to two groups: a functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) group and a control group. Individuals in the fMRI-rTMS group (n = 40) will receive high-frequency rTMS (10 Hz, 120% MT). The main target of stimulation will be the area most relevant to the functional connectivity of the right medial prefrontal cortex (mPFC) and amygdala. The control group (n = 40) will receive sham stimulation, with a coil flipped to 90 degrees relative to the vertical scalp. All patients will receive 15 consecutive days of treatment, with each session lasting half an hour per day, followed by 8 weeks of follow-up. The primary outcome is the comparison of Oxford Depression Questionnaire (ODQ) scores between these two groups at different time points. The secondary outcomes include evaluating other clinical scales and assessing the differences in brain imaging changes between the two groups before and after treatment.

DISCUSSION

This trial aims to examine the effects of functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) intervention on depressed patients experiencing emotional blunting and to elucidate the potential mechanism behind it. The results will provide new evidence for using fMRI-rTMS in treating depression with emotional blunting in the future.

TRIAL REGISTRATION

ClinicalTrials.gov INCT05555940. Registered on 13 September 2022 at http://clinicaltrials.gov .

摘要

背景

情感迟钝是抑郁症患者一直存在的症状。重复经颅磁刺激（rTMS）是一种安全有效的辅助治疗抑郁症的方法。然而，在随机对照试验中，尚未观察到功能磁共振成像引导的个性化 rTMS（fMRI-rTMS）治疗情感迟钝抑郁症的疗效和脑影像学过程。

方法

这是一项随机、对照、双盲、单中心的临床试验，将 80 名符合条件的有情感迟钝的抑郁症患者随机分为两组：功能磁共振成像引导的个性化 rTMS（fMRI-rTMS）组和对照组。fMRI-rTMS 组（n=40）的个体将接受高频 rTMS（10 Hz，120% MT）。刺激的主要目标是与右侧内侧前额叶皮质（mPFC）和杏仁核的功能连接最相关的区域。对照组（n=40）将接受假刺激，线圈相对于垂直头皮翻转 90 度。所有患者将接受 15 天的连续治疗，每天治疗半小时，随后进行 8 周的随访。主要结局是两组在不同时间点的牛津抑郁问卷（ODQ）评分比较。次要结局包括评估其他临床量表，并评估治疗前后两组脑影像学变化的差异。