nctId: NCT06372028 id: 944/A briefTitle: Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) acronym: (BOOSTTVNS) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-05-14 date: 2024-04-17 date: 2024-04-17 name: IRCCS Eugenio Medea class: OTHER name: IRCCS National Neurological Institute "C. Mondino" Foundation name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, taking into account that tVNS has the potential to facilitate in a bottom-up way neural plasticity, particularly in chronic disease conditions, the investigators hypothesized that active tVNS might improve in a greater and more lasting extent than sham tVNS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in paediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: transcutaneous vagus nerve stimulation (tVNS) measure: Assisting Hand Assessment (AHA) measure: Box and Block Test (BBT) measure: Visuomotor task measure: Canadian Occupational Performance Measure (COPM) measure: Children's Hand-UseExperienceQuestionnaire (CHEQ) measure: Melbourne Assessment 2 (MA2) measure: Gross Motor Function Measure (GMFM-66) measure: Vineland Adaptive Behavior Scale Version 2 (VABS II) measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) measure: Heart rate (HR). measure: Oxygen saturation (SPO2). measure: Tolerability of the stimulation measure: Number of patients who accept to complete the 2-week training measure: Number of sessions completed per patient measure: Acceptability of the training sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute, IRCCS E. Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Alessandra Finisguerra role: CONTACT phone: +39031877652 email: alessandra.finisguerra@lanostrafamiglia.it name: Cosimo Urgesi role: CONTACT email: cosimo.urgesi@lanostrafamiglia.it name: Viola Oldrati role: SUB_INVESTIGATOR lat: 45.80075 lon: 9.29 hasResults: False