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用于缓解呼吸困难的非侵入性神经调节:一项可行性假对照随机试验的方案

Non-invasive neuromodulation for alleviating dyspnoea: protocol for a feasibility sham-controlled randomised trial.

作者信息

St-Pierre Joël, Mailhot-Larouche Samuel, Garand Geneviève, Vézina Félix-Antoine, Léonard Guillaume, Iorio-Morin Christian, Couillard Simon

机构信息

Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, Sherbrooke, Quebec, Canada.

Centre de Recherche du CHUS, Sherbrooke, Quebec, Canada.

出版信息

BMJ Open. 2025 Jul 22;15(7):e103891. doi: 10.1136/bmjopen-2025-103891.


DOI:10.1136/bmjopen-2025-103891
PMID:40701604
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12306373/
Abstract

INTRODUCTION: Dyspnoea affects 10% of the general population, and 12% of hospitalised patients report experiencing dyspnoea at rest. It is a common and distressing symptom experienced by people living with chronic obstructive pulmonary disease (COPD). Neuromodulation, which uses electrical stimulation to modulate neural pathways, is a validated clinical procedure offering a potential therapeutic approach. We speculate that non-invasive transcutaneous vagus nerve stimulation (tVNS) and trigeminal transcutaneous electric nerve stimulation (TENS) could improve dyspnoea management by targeting relevant neural circuits. METHODS AND ANALYSIS: We will conduct a feasibility cross-over trial in people with severe COPD and significant exertional dyspnoea referred for pulmonary rehabilitation. Patients will be recruited following the prerehabilitation assessment visit comprising a clinical evaluation and a maximal cardiopulmonary exercise testing on ergocycle. Subsequently, two study visits will be conducted within 2 weeks apart from each other. Eight participants will perform a submaximal constant work rate at 80% workload of the VO max, either with cervical tVNS (n=4) or trigeminal TENS (n=4). In a cross-over design, both patient groups will undergo sham and active treatment of the neuromodulation technique in a randomly assigned order. The main outcome will be feasibility, assessed by the percentage of patients who attend all visits and complete all tests. Secondary outcomes include other feasibility endpoints, the acceptability and suitability of the interventions (including an evaluation of sham as an exploratory outcome), and the incidence of adverse or undesirable events related to the procedures. Exploratory outcomes include changes in dyspnoea symptoms, measured using standardised questionnaires, such as Borg scale and the Visual Analogue Scale. ETHICS AND DISSEMINATION: The protocol is approved by the institutional research ethics committee of the -CHUS, Sherbrooke, Quebec, Canada (#2025-5604) and follows guidelines. Results will be communicated in international meetings and submitted to peer-reviewed journals with respect to the statement for feasibility studies. TRIAL REGISTRATION NUMBER: NCT06985628.

摘要

引言:呼吸困难影响着10%的普通人群,12%的住院患者报告在静息时出现呼吸困难。它是慢性阻塞性肺疾病(COPD)患者常见且令人痛苦的症状。神经调节利用电刺激来调节神经通路,是一种经过验证的临床程序,提供了一种潜在的治疗方法。我们推测,非侵入性经皮迷走神经刺激(tVNS)和三叉神经经皮电刺激(TENS)可以通过靶向相关神经回路来改善呼吸困难的管理。 方法与分析:我们将对因严重COPD和显著运动性呼吸困难而被转诊进行肺康复的患者进行一项可行性交叉试验。患者将在康复前评估访视后招募,该访视包括临床评估和在测力计上进行的最大心肺运动测试。随后,将在相隔2周内进行两次研究访视。8名参与者将在VO max的80%工作量下进行次最大恒定工作率,分别采用颈部tVNS(n = 4)或三叉神经TENS(n = 4)。在交叉设计中,两组患者将以随机分配的顺序接受神经调节技术的假刺激和主动治疗。主要结果将是可行性,通过参加所有访视并完成所有测试的患者百分比来评估。次要结果包括其他可行性终点、干预措施的可接受性和适用性(包括将假刺激评估作为探索性结果),以及与程序相关的不良或不良事件的发生率。探索性结果包括使用标准化问卷(如Borg量表和视觉模拟量表)测量的呼吸困难症状的变化。 伦理与传播:该方案已获得加拿大魁北克省舍布鲁克市CHUS的机构研究伦理委员会批准(#2025 - 5604),并遵循相关指南。结果将在国际会议上公布,并根据可行性研究的声明提交给同行评审期刊。 试验注册号:NCT06985628。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52e3/12306373/a19dabef4171/bmjopen-15-7-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52e3/12306373/a19dabef4171/bmjopen-15-7-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52e3/12306373/a19dabef4171/bmjopen-15-7-g001.jpg

相似文献

[1]
Non-invasive neuromodulation for alleviating dyspnoea: protocol for a feasibility sham-controlled randomised trial.

BMJ Open. 2025-7-22

[2]
Telehealth interventions: remote monitoring and consultations for people with chronic obstructive pulmonary disease (COPD).

Cochrane Database Syst Rev. 2021-7-20

[3]
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[4]
Pulmonary rehabilitation for chronic obstructive pulmonary disease.

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[5]
Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults.

Cochrane Database Syst Rev. 2017-9-14

[6]
Upper limb exercise training for COPD.

Cochrane Database Syst Rev. 2016-11-15

[7]
Individual-level interventions to reduce personal exposure to outdoor air pollution and their effects on people with long-term respiratory conditions.

Cochrane Database Syst Rev. 2021-8-9

[8]
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Cochrane Database Syst Rev. 2016-10-17

[9]
TRanscutaneous lImb reCovEry Post-Stroke (TRICEPS): study protocol for a randomised, controlled, multiarm, multistage adaptive design trial.

BMJ Open. 2025-3-26

[10]
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本文引用的文献

[1]
Neuromodulation of dyspnea - A literature review.

Respir Med. 2025-7

[2]
Sham controls in device trials for chronic pain - tricky in practice-a review article.

Contemp Clin Trials Commun. 2023-8-22

[3]
Prevalence of dyspnea in general adult populations: A systematic review and meta-analysis.

Respir Med. 2023-11

[4]
Efficacy of transcutaneous electrical nerve stimulation (TENS) in the management of trigeminal neuralgia: A systematic review and meta-analysis.

J Clin Exp Dent. 2023-6-1

[5]
Impact of trigeminal nerve and/or olfactory nerve stimulation on activity of human brain regions involved in the perception of breathlessness.

Respir Physiol Neurobiol. 2023-5

[6]
A Methodological Perspective on the Function and Assessment of Peripheral Chemoreceptors in Heart Failure: A Review of Data from Clinical Trials.

Biomolecules. 2022-11-26

[7]
Evaluation of the Individual Activity Descriptors of the mMRC Breathlessness Scale: A Mixed Method Study.

Int J Chron Obstruct Pulmon Dis. 2022

[8]
Clinical outcomes and complications of peripheral nerve field stimulation in the management of refractory trigeminal pain: a systematic review and meta-analysis.

J Neurosurg. 2022-2-18

[9]
TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

PLoS Med. 2020-9-21

[10]
Stimulus frequency modulates brainstem response to respiratory-gated transcutaneous auricular vagus nerve stimulation.

Brain Stimul. 2020-3-27

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