1. Neuromodulation-induced prehabilitation to leverage neuroplasticity before brain tumor surgery: a single-cohort feasibility trial protocol
- Author
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Leonardo Boccuni, Kilian Abellaneda-Pérez, Jesús Martín-Fernández, David Leno-Colorado, Alba Roca-Ventura, Alba Prats Bisbe, Edgar Antonio Buloz-Osorio, David Bartrés-Faz, Nuria Bargalló, María Cabello-Toscano, José Carlos Pariente, Emma Muñoz-Moreno, Carlo Trompetto, Lucio Marinelli, Gloria Villalba-Martinez, Hugues Duffau, Álvaro Pascual-Leone, and Josep María Tormos Muñoz
- Subjects
brain tumor ,neuro-oncology ,prehabilitation ,neuromodulation ,neurorehabilitation ,neurosurgery ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
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.
- Published
- 2023
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