Neuromodulation-induced prehabilitation to leverage neuroplasticity before brain tumor surgery: a single-cohort feasibility trial protocol

Frontiers in Neurology

Neurology

Lucio Marinelli¹  Carlo Trompetto²  Gloria Villalba-Martinez³  Jesús Martín-Fernández⁴  Hugues Duffau⁵  Emma Muñoz-Moreno⁶  Álvaro Pascual-Leone⁷  Josep María Tormos Muñoz⁸  David Bartrés-Faz⁹  María Cabello-Toscano⁹  Alba Roca-Ventura^1,10  Alba Prats Bisbe^1,11  Leonardo Boccuni^1,11  Kilian Abellaneda-Pérez^1,11  David Leno-Colorado^1,11  Edgar Antonio Buloz-Osorio^1,12  José Carlos Pariente^1,13  Nuria Bargalló^1,14 

[1] Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Genova, Italy;Department of Neuroscience, Division of Clinical Neurophysiology, IRCCS Ospedale Policlinico San Martino, Genova, Italy;Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Genova, Italy;Department of Neuroscience, Division of Neurorehabilitation, IRCCS Ospedale Policlinico San Martino, Genova, Italy;Department of Neurosurgery, Hospital del Mar, Barcelona, Spain;Department of Neurosurgery, Hôpital Gui de Chauliac, Montpellier, France;Department of Neurosurgery, Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain;Department of Basic Medical Sciences, Universidad de La Laguna, Tenerife, Spain;Department of Neurosurgery, Hôpital Gui de Chauliac, Montpellier, France;Institute of Functional Genomics, University of Montpellier, CNRS, INSERM, Montpellier, France;Experimental 7T MRI Unit, Magnetic Resonance Imaging Core Facility, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain;Hinda and Arthur Marcus Institute for Aging Research and Deanna and Sidney Wolk Center for Memory Health, Hebrew Senior Life, Boston, MA, United States;Department of Neurology, Harvard Medical School, Boston, MA, United States;Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la UAB, Badalona, Barcelona, Spain;Centro de Investigación Traslacional San Alberto Magno, Facultad de Medicina y Ciencias de la Salud, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain;Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la UAB, Badalona, Barcelona, Spain;Department of Medicine, Faculty of Medicine and Health Sciences, Institute of Neurosciences, University of Barcelona, Barcelona, Spain;Institut de Recerca Biomèdica August Pi i Sunyer (IDIBAPS), Barcelona, Spain;Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la UAB, Badalona, Barcelona, Spain;Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Barcelona, Spain;Department of Medicine, Faculty of Medicine and Health Sciences, Institute of Neurosciences, University of Barcelona, Barcelona, Spain;Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la UAB, Badalona, Barcelona, Spain;Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain;Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Barcelona, Spain;Institut Guttmann, Institut Universitari de Neurorehabilitació adscrit a la UAB, Badalona, Barcelona, Spain;Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain;Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Barcelona, Spain;Department of Morphological Sciences (Human Anatomy and Embriology Unit), Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain;Institut de Recerca Biomèdica August Pi i Sunyer (IDIBAPS), Barcelona, Spain;Institut de Recerca Biomèdica August Pi i Sunyer (IDIBAPS), Barcelona, Spain;Centre de Diagnòstic per la Imatge Clínic, Hospital Clínic de Barcelona, Barcelona, Spain;

关键词: brain tumor;    neuro-oncology;    prehabilitation;    neuromodulation;    neurorehabilitation;    neurosurgery;    neuroplasticity;    clinical trial;   

DOI  :  10.3389/fneur.2023.1243857

 received in 2023-06-21, accepted in 2023-09-04,  发布年份 2023

来源: Frontiers

【 摘 要 】

IntroductionNeurosurgery 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.Methods and analysisPatients 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 and disseminationEthics approval was obtained from the Research Ethical Committee of Fundació Unió Catalana d'Hospitals (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.Clinical trial registrationClinicalTrials.gov, identifier NCT05844605.

【 授权许可】

Unknown   
Copyright © 2023 Boccuni, Abellaneda-Pérez, Martín-Fernández, Leno-Colorado, Roca-Ventura, Prats Bisbe, Buloz-Osorio, Bartrés-Faz, Bargalló, Cabello-Toscano, Pariente, Muñoz-Moreno, Trompetto, Marinelli, Villalba-Martinez, Duffau, Pascual-Leone and Tormos Muñoz.