NCT06372028

Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS)

tVNS-combined Motor Training for the Rehabilitation of the Upper Limb in Children and Young People With Cerebral Palsy: a Randomized, Sham-controlled Trial
IRCCS Eugenio Medea·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Cerebral Palsy
Drug/Device/Intervention
transcutaneous vagus nerve stimulation (tVNS)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
IRCCS Eugenio Medea
Location
Bosisio Parini, Italy
Timeline & enrollment
Phase
N/A
Start date
Apr 15, 2024
End date
May 14, 2026
Enrollment
44 participants
Primary outcome

Assisting Hand Assessment (AHA),Box and Block Test (BBT),Visuomotor task

Summary

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.

ICD-10 classifications
Cerebral palsyOther cerebral palsyCerebral palsy, unspecifiedDyskinetic cerebral palsyAtaxic cerebral palsy
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06372028
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06372028 through Pure Global AI's free database. This phase not specified trial is sponsored by IRCCS Eugenio Medea and is currently Not yet recruiting. The study focuses on Cerebral Palsy. Target enrollment is 44 participants.

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