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STUDY PROTOCOL article

Front. Neurol.
Sec. Neurorehabilitation
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1441128
This article is part of the Research Topic Neurologic Correlates of Motor Function in Cerebral Palsy: Opportunities for Targeted Treatment, Volume II View all 5 articles

Pairing transcutaneous Vagus Nerve Stimulation (tVNS) with an intensive bimanual training in children and adolescents with cerebral palsy: study protocol of a randomized shamcontrolled trial

Provisionally accepted
Viola Oldrati Viola Oldrati 1*Verusca Gasparroni Verusca Gasparroni 1Arianna Michelutti Arianna Michelutti 1Andrea Ciricugno Andrea Ciricugno 2Renato Borgatti Renato Borgatti 2Simona Orcesi Simona Orcesi 2Elisa Fazzi Elisa Fazzi 3Morandi Alessandra Morandi Alessandra 4Jessica Galli Jessica Galli 3Luigi Piccinini Luigi Piccinini 1Maghini Cristina Maghini Cristina 1Maria Arioli Maria Arioli 5Zaira Cattaneo Zaira Cattaneo 5Cosimo Urgesi Cosimo Urgesi 6Alessandra Finisguerra Alessandra Finisguerra 1
  • 1 Scientific Institute, IRCCS E. Medea, Bosisio Parini (LC), Italy
  • 2 Neurological Institute Foundation Casimiro Mondino (IRCCS), Pavia, Lombardy, Italy
  • 3 Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Lombardy, Italy
  • 4 Other, Brescia, Italy
  • 5 Department of Human and Social Sciences, University of Bergamo, Bergamo, Lombardy, Italy
  • 6 Laboratory of Cognitive Neuroscience, Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy

The final, formatted version of the article will be published soon.

    Background: Gross motor function impairments and manual dexterity deficits are frequently observed in children and adolescents with Cerebral Palsy (CP), having a major impact on their activity level and autonomy. Improving manual dexterity and activity level of patients with CP is often the focus of rehabilitation. Novel and adjuvant treatment methods that could support the standard training also in chronic conditions are a research priority. The transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive brain stimulation technique which provides a bottom-up stimulation of subcortical and cortical brain structures, enhancing brain GABA and Noradrenaline levels. This technique may play a pivotal role in brain plasticity, which has not been tested in CP patients before.Method: 44 children and adolescents with CP will be involved, treated in pairs in a randomized, double-blind, pre-post test study. The two groups will undergo the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for two consecutive weeks, with 3h daily sessions for five days per week, for an overall time interval of 30 hours; the training will be combined with the application for 75 minutes/day of active or sham tVNS, in separate, randomly allocated groups. The primary outcome measure will include the scores at the Assisting Hand Assessment and Box and Block Test, and at an ad-hoc visuomotor task evaluating manual visuomotor control. Secondary outcomes will include the scores at the Children's Hand Experience Questionnaire, Canadian Occupational Performance Measure, Melbourne Assessment of Unilateral Upper Limb Function, Gross Motor Function Measure, Vineland, Pediatric quality of life inventory. The evaluation points will include pre (T0), post (T1) and 3-month follow up (T2) assessments. Safety and tolerability will also be assessed.The results of this trial will assess whether tVNS can effectively boost the effects of an intensive twoweek bimanual training, in improving manual dexterity in children and adolescents with cerebral palsy, ensuring safety and tolerability throughout the intervention period.Trial registry number: NCT06372028 (ClinicalTrials.gov Identifier)

    Keywords: Cerebral Palsy, Transcutaneous vagus nerve stimulation, Habit-ile, Upper limbs motor, tVNS

    Received: 30 May 2024; Accepted: 30 Jul 2024.

    Copyright: © 2024 Oldrati, Gasparroni, Michelutti, Ciricugno, Borgatti, Orcesi, Fazzi, Alessandra, Galli, Piccinini, Cristina, Arioli, Cattaneo, Urgesi and Finisguerra. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Viola Oldrati, Scientific Institute, IRCCS E. Medea, Bosisio Parini (LC), Italy

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.