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使用加速间歇性theta爆发刺激(ADEPT)治疗与脑震荡相关的抑郁症状的适应性试验:原理、设计与方法

Adaptive trial for the treatment of depressive symptoms associated with concussion using accelerated intermittent theta burst stimulation (ADEPT): rationale, design and methods.

作者信息

Oberman Lindsay M, Penafiel Adriana I, Dieterich Rachel, Phan Cuong T, Chou Yi-Yu, Pham Dzung L, Adamson Maheen M, Hines Christopher E, Rezaee Zeynab, Deng Zhi-De, Pal Hemant, Lisanby Sarah H, Brody David L

机构信息

National Institute of Mental Health Intramural Research Program, Bethesda, MD, United States.

Henry M. Jackson Foundation for the Advancement of Military Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, United States.

出版信息

Front Neurol. 2025 Jun 13;16:1605157. doi: 10.3389/fneur.2025.1605157. eCollection 2025.


DOI:10.3389/fneur.2025.1605157
PMID:40584527
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12202228/
Abstract

UNLABELLED: Military service members (SMs) and veterans who have sustained one or more concussions during their service have significantly higher rates of persistent depressive symptoms and suicidality compared to non-injured peers. Despite over 500,000 SMs who have sustained concussions, there are currently no Level I evidence-based treatments for improving depressive symptoms associated with concussion. Accelerated intermittent theta burst stimulation (aiTBS), a specific repetitive transcranial magnetic stimulation (rTMS) protocol, targeted at the dorsolateral prefrontal cortex (DLPFC) has demonstrated efficacy and is cleared for the treatment of Major Depressive Disorder (MDD) by the United States Food and Drug Administration (FDA). The mechanism of action of aiTBS is thought to be via the modulation of functional networks. Herein we outline the design of a multisite, double-blind, randomized, sham-controlled trial of aiTBS for the treatment of depressive symptoms in SMs and veterans with a history of concussion. We present the rationale for this specific design and highlight the potential for personalized neuroimaging-informed parameter determination in this population where brain injuries have resulted in variable structural and functional brain circuitry disruptions. If successful, this project will accelerate solutions to improve the health, well-being, and healthcare of SMs and veterans with depressive symptoms following concussion. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT05426967.

摘要

未标注:与未受伤的同龄人相比,在服役期间遭受过一次或多次脑震荡的军人和退伍军人出现持续性抑郁症状和自杀倾向的比例要高得多。尽管有超过50万军人遭受过脑震荡,但目前尚无基于一级证据的治疗方法来改善与脑震荡相关的抑郁症状。加速间歇性theta爆发刺激(aiTBS)是一种针对背外侧前额叶皮质(DLPFC)的特定重复经颅磁刺激(rTMS)方案,已证明具有疗效,并已获得美国食品药品监督管理局(FDA)批准用于治疗重度抑郁症(MDD)。aiTBS的作用机制被认为是通过调节功能网络。在此,我们概述了一项多中心、双盲、随机、假对照试验的设计,该试验旨在研究aiTBS对有脑震荡病史的军人和退伍军人抑郁症状的治疗效果。我们阐述了这一特定设计的基本原理,并强调了在这个因脑损伤导致结构和功能脑回路出现不同程度破坏的人群中,利用个性化神经影像信息确定参数的潜力。如果该项目取得成功,将加快解决改善有脑震荡后抑郁症状的军人和退伍军人的健康、福祉及医疗保健问题的进程。 临床试验注册:Clinicaltrials.gov,NCT05426967。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/906cdbdc54ff/fneur-16-1605157-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/da35be6c2fae/fneur-16-1605157-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/45ac34803775/fneur-16-1605157-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/906cdbdc54ff/fneur-16-1605157-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/da35be6c2fae/fneur-16-1605157-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/45ac34803775/fneur-16-1605157-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1e2/12202228/906cdbdc54ff/fneur-16-1605157-g003.jpg

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本文引用的文献

[1]
Neural mechanisms of emotional health in traumatic brain injury patients undergoing rTMS treatment.

Mol Psychiatry. 2023-12

[2]
Precision functional MRI mapping reveals distinct connectivity patterns for depression associated with traumatic brain injury.

Sci Transl Med. 2023-7-5

[3]
Individualized precision targeting of dorsal attention and default mode networks with rTMS in traumatic brain injury-associated depression.

Sci Rep. 2023-3-11

[4]
Differences in Disease Non-battle Injury Between Combatant Commands.

Mil Med. 2023-7-22

[5]
TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation.

J Neural Eng. 2022-4-21

[6]
Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial.

Am J Psychiatry. 2022-2

[7]
Brain stimulation and brain lesions converge on common causal circuits in neuropsychiatric disease.

Nat Hum Behav. 2021-12

[8]
Individual-Specific Areal-Level Parcellations Improve Functional Connectivity Prediction of Behavior.

Cereb Cortex. 2021-8-26

[9]
The Bayesian Design of Adaptive Clinical Trials.

Int J Environ Res Public Health. 2021-1-10

[10]
Functional Magnetic Resonance Imaging-Guided Personalization of Transcranial Magnetic Stimulation Treatment for Depression.

JAMA Psychiatry. 2021-3-1

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