OBJECTIVE: This study explores the known relationship between the autonomic nervous system and inflammatory pathways to improve patient outcomes by treating autonomic nervous system dysregulation in patients via noninvasive vagus nerve stimulation. In this study, data including biomarkers, physiological signals, patient outcomes, and patient quality of life are being collected and analyzed. After completion of the clinical trial, a computer model will be developed to identify the biomarkers and physiological signals related to lupus activity in order to understand how they change with different noninvasive vagus nerve stimulation frequency parameters. Finally, we propose building a decision support system with integrated noninvasive wearable technologies for continuous cardiovascular and peripheral physiological sensing for adaptive, patient-specific optimization of the noninvasive vagus nerve stimulation frequency parameters in real time.
METHODS: The protocol was designed to evaluate the efficacy and safety of transauricular vagus nerve stimulation in patients with systemic lupus erythematosus. This multicenter, national, randomized, double-blind, parallel-group, placebo-controlled study will recruit a minimum of 18 patients diagnosed with this disease. Evaluation and treatment of patients will be conducted in an outpatient clinic and will include 12 visits. Visit 1 consists of a screening session. Subsequent visits up to visit 6 involve mixing treatment and evaluation sessions. Finally, the remaining visits correspond with early and late posttreatment follow-ups.
RESULTS: On November 2022, data collection was initiated. Of the 10 participants scheduled for their initial appointment, 8 met the inclusion criteria, and 6 successfully completed the entire protocol. Patient enrollment and data collection are currently underway and are expected to be completed in December 2023.
CONCLUSIONS: The results of this study will advance patient-tailored vagus nerve stimulation therapies, providing an adjunctive treatment solution for systemic lupus erythematosus that will foster adoption of technology and, thus, expand the population with systemic lupus erythematosus who can benefit from improved autonomic dysregulation, translating into reduced costs and better quality of life.
BACKGROUND: ClinicalTrials.gov NCT05704153; https://clinicaltrials.gov/study/NCT05704153.
UNASSIGNED: DERR1-10.2196/48387.
目的:本研究探讨了自主神经系统与炎症通路之间的已知关系,通过无创迷走神经刺激治疗患者的自主神经系统失调来改善患者的预后。在这项研究中,数据包括生物标志物,生理信号,患者结果,和患者的生活质量正在被收集和分析。临床试验完成后,将开发一个计算机模型来识别与狼疮活动相关的生物标志物和生理信号,以了解它们如何随着不同的非侵入性迷走神经刺激频率参数而变化。最后,我们建议建立一个决策支持系统,集成非侵入式可穿戴技术,用于连续的心血管和外周生理传感,实时优化非侵入性迷走神经刺激频率参数。
方法:该方案旨在评估经耳廓迷走神经刺激对系统性红斑狼疮患者的疗效和安全性。这个多中心,国家,随机化,双盲,平行组,安慰剂对照研究将招募至少18名被诊断患有这种疾病的患者。患者的评估和治疗将在门诊进行,包括12次就诊。访问1包括筛选会议。随后的访问直到访问6包括混合治疗和评估会议。最后,其余访视与治疗后的早期和晚期随访相对应.
结果:2022年11月,开始数据收集。在预定初次任命的10名参与者中,8符合纳入标准,和6成功完成了整个协议。目前正在进行患者登记和数据收集,预计将于2023年12月完成。
结论:这项研究的结果将促进患者定制的迷走神经刺激疗法,为系统性红斑狼疮提供辅助治疗解决方案,这将促进技术的采用,因此,扩大可以从改善自主神经失调中受益的系统性红斑狼疮的人群,转化为降低成本和更好的生活质量。
背景:ClinicalTrials.govNCT05704153;https://clinicaltrials.gov/study/NCT05704153。
■DERR1-10.2196/48387。