Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS)
- Disease/Condition
- Cerebral Palsy
- Drug/Device/Intervention
- transcutaneous vagus nerve stimulation (tVNS)
- Study type
- Interventional
- Intervention type
- device
- Primary sponsor
- IRCCS Eugenio Medea
- Location
- Bosisio Parini, Italy
- Phase
- N/A
- Start date
- Apr 15, 2024
- End date
- May 14, 2026
- Enrollment
- 44 participants
Assisting Hand Assessment (AHA),Box and Block Test (BBT),Visuomotor task
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06372028
- Type
- Device Trial
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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