Boccuni Leonardo, Abellaneda-Pérez Kilian, Martín-Fernández Jesús, Leno-Colorado David, Roca-Ventura Alba, Prats Bisbe Alba, Buloz-Osorio Edgar Antonio, Bartrés-Faz David, Bargalló Nuria, Cabello-Toscano María, Pariente José Carlos, Muñoz-Moreno Emma, Trompetto Carlo, Marinelli Lucio, Villalba-Martinez Gloria, Duffau Hugues, Pascual-Leone Álvaro, Tormos Muñoz Josep María
Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la UAB, Badalona, Barcelona, Spain.
Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain.
Front Neurol. 2023 Oct 2;14:1243857. doi: 10.3389/fneur.2023.1243857. eCollection 2023.
Neurosurgery for brain tumors needs to find a complex balance between the effective removal of targeted tissue and the preservation of surrounding brain areas. Neuromodulation-induced cortical prehabilitation (NICP) is a promising strategy that combines temporary inhibition of critical areas (virtual lesion) with intensive behavioral training to foster the activation of alternative brain resources. By progressively reducing the functional relevance of targeted areas, the goal is to facilitate resection with reduced risks of neurological sequelae. However, it is still unclear which modality (invasive vs. non-invasive neuromodulation) and volume of therapy (behavioral training) may be optimal in terms of feasibility and efficacy.
Patients undertake between 10 and 20 daily sessions consisting of neuromodulation coupled with intensive task training, individualized based on the target site and neurological functions at risk of being compromised. The primary outcome of the proposed pilot, single-cohort trial is to investigate the feasibility and potential effectiveness of a non-invasive NICP protocol on neuroplasticity and post-surgical outcomes. Secondary outcomes investigating longitudinal changes (neuroimaging, neurophysiology, and clinical) are measured pre-NICP, post-NICP, and post-surgery.
Ethics approval was obtained from the Research Ethical Committee of (approval number: CEI 21/65, version 1, 13/07/2021). The results of the study will be submitted to a peer-reviewed journal and presented at scientific congresses.
ClinicalTrials.gov, identifier NCT05844605.
脑肿瘤神经外科手术需要在有效切除目标组织与保护周围脑区之间找到复杂的平衡。神经调节诱导的皮质预康复（NICP）是一种很有前景的策略，它将关键区域的临时抑制（虚拟损伤）与强化行为训练相结合，以促进替代脑资源的激活。通过逐步降低目标区域的功能相关性，目标是在降低神经后遗症风险的情况下促进切除手术。然而，就可行性和有效性而言，哪种方式（侵入性与非侵入性神经调节）和治疗量（行为训练）可能是最佳的仍不清楚。
患者每天进行10至20次治疗，包括神经调节与强化任务训练，根据目标部位和有受损风险的神经功能进行个体化训练。拟进行的这项试点单队列试验的主要结果是研究非侵入性NICP方案对神经可塑性和术后结果的可行性及潜在有效性。在NICP前、NICP后和手术后测量研究纵向变化（神经影像学、神经生理学和临床）的次要结果。
已获得 研究伦理委员会的伦理批准（批准号：CEI 21/65，版本1，2021年7月13日）。研究结果将提交给同行评审期刊，并在科学大会上展示。
ClinicalTrials.gov，标识符NCT05844605。
