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个性化神经调节缓解多发性硬化症疲劳:一项多中心试点研究[FaremusGE]

Fatigue relief in multiple sclerosis by personalized neuromodulation: A multicenter pilot study [FaremusGE].

作者信息

Tecchio Franca, Bertoli Massimo, Sbragia Elvira, Stara Silvia, Pasqualetti Patrizio, L'Abbate Teresa, Croce Pierpaolo, Pizzichino Arianna, Cancelli Andrea, Armonaite Karolina, Cecconi Federico, Paulon Luca, Inglese Matilde

机构信息

Laboratory of Electrophysiology for Translational neuroScience (LET'S), Istituto di Scienze e Tecnologie della Cognizione (ISTC), Consiglio Nazionale delle Ricerche (CNR), Rome, Italy.

Laboratory of Electrophysiology for Translational neuroScience (LET'S), Istituto di Scienze e Tecnologie della Cognizione (ISTC), Consiglio Nazionale delle Ricerche (CNR), Rome, Italy; Department of Neuroscience, Imaging and Clinical Sciences, University 'G. D'Annunzio' of Chieti-Pescara, Chieti, Italy.

出版信息

Mult Scler Relat Disord. 2025 Feb;94:106276. doi: 10.1016/j.msard.2025.106276. Epub 2025 Jan 18.

DOI:10.1016/j.msard.2025.106276
PMID:39842388
Abstract

BACKGROUND

A recent application of the GRADE guidelines indicated Faremus, a 5-day neuromodulation for 15 min per day via transcranial direct current stimulation (tDCS), as medium to highly recommendable for alleviating fatigue in multiple sclerosis (MS).

METHODS

With this pilot study we aimed to evaluate the feasibility, acceptance, safety, and effectiveness of the Faremus treatment carried out in a multicenter context. The Rome unit prepared the intervention, supplied the personalized electrodes to the San Martino Hospital in Genova, where the neurological team enrolled the population of fatigued people with multiple sclerosis (PwMS) and carried out the treatment.

RESULTS

All 17 enrolled patients completed treatment, reporting optimal acceptance and safety when using Faremus in the multicenter setting. The team involved, including neurologists, neurophysiopathology technicians, engineers, physicists, and psychologists expressed high appreciation (average score 8 out of 10). The treatment improved fatigue symptoms by an average of 27%, to levels comparable with previous studies. Similarly, mild depressive symptoms improved by an average of 38%.

CONCLUSIONS

The Faremus personalized electroceutical intervention, a 5-day anodal tDCS over bilateral whole-body somatosensory cortex with occipital cathode, is well accepted and can be applied feasibly, safely and effectively in a multicenter setting, offering a reliable tool to relieve fatigue-related symptoms, thus supporting the quality of life of fatigued people with MS. The present study lays a starting point for the involvement of multiple MS units nationwide in offering therapeutic enrichment for their fatigued patients.

摘要

背景

最近应用的GRADE指南表明,Faremus(一种通过经颅直流电刺激(tDCS)每天15分钟,持续5天的神经调节方法)在缓解多发性硬化症(MS)疲劳方面具有中等到高度的推荐性。

方法

在这项初步研究中,我们旨在评估在多中心环境中进行的Faremus治疗的可行性、可接受性、安全性和有效性。罗马团队准备了干预措施,向热那亚的圣马蒂诺医院提供了个性化电极,神经科团队在该医院招募了多发性硬化症疲劳患者群体并进行治疗。

结果

所有17名入组患者均完成治疗,报告称在多中心环境中使用Faremus时具有最佳的可接受性和安全性。参与的团队,包括神经科医生、神经生理病理技术员、工程师、物理学家和心理学家都给予了高度评价(平均评分8分(满分10分))。治疗使疲劳症状平均改善了27%,达到了与先前研究相当的水平。同样,轻度抑郁症状平均改善了38%。

结论

Faremus个性化电疗干预,即对双侧全身体感皮层进行为期5天的阳极tDCS并辅以枕部阴极,具有良好的可接受性,并且可以在多中心环境中安全有效地应用,为缓解疲劳相关症状提供了可靠工具,从而支持多发性硬化症疲劳患者的生活质量。本研究为全国多个多发性硬化症治疗单位参与为其疲劳患者提供治疗丰富手段奠定了起点。

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