protocolSection identificationModule nctId: NCT06372028, orgStudyIdInfo id: 944/A, briefTitle: Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS), acronym: (BOOSTTVNS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-05-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, collaborators name: IRCCS National Neurological Institute "C. Mondino" Foundation, collaborators name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, descriptionModule 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., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: transcutaneous vagus nerve stimulation (tVNS), outcomesModule primaryOutcomes measure: Assisting Hand Assessment (AHA), primaryOutcomes measure: Box and Block Test (BBT), primaryOutcomes measure: Visuomotor task, secondaryOutcomes measure: Canadian Occupational Performance Measure (COPM), secondaryOutcomes measure: Children's Hand-UseExperienceQuestionnaire (CHEQ), secondaryOutcomes measure: Melbourne Assessment 2 (MA2), secondaryOutcomes measure: Gross Motor Function Measure (GMFM-66), secondaryOutcomes measure: Vineland Adaptive Behavior Scale Version 2 (VABS II), secondaryOutcomes measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL), otherOutcomes measure: Heart rate (HR)., otherOutcomes measure: Oxygen saturation (SPO2)., otherOutcomes measure: Tolerability of the stimulation, otherOutcomes measure: Number of patients who accept to complete the 2-week training, otherOutcomes measure: Number of sessions completed per patient, otherOutcomes measure: Acceptability of the training, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Scientific Institute, IRCCS E. Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Alessandra Finisguerra, role: CONTACT, phone: +39031877652, email: alessandra.finisguerra@lanostrafamiglia.it, contacts name: Cosimo Urgesi, role: CONTACT, email: cosimo.urgesi@lanostrafamiglia.it, contacts name: Viola Oldrati, role: SUB_INVESTIGATOR, geoPoint lat: 45.80075, lon: 9.29, hasResults: False