Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS)

NANot yet recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

March 14, 2026

Study Completion Date

May 14, 2026

Conditions
Cerebral Palsy
Interventions
DEVICE

transcutaneous vagus nerve stimulation (tVNS)

tVNS allows the non-invasive stimulation of the Vagus Nerve by delivering electrical pulses to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. TVNS seems to engage the same neural pathways of invasive VNS methods and may provide a novel, bottom-up NIBS method to enhance gamma-aminobutyric acid and Noradrenaline levels, which play a pivotal role in brain plasticity. The stimulation will be performed by using a Conformite Europeenne (CE) marked tVNS device tVNS®E (tVNS, technologies Gesellschaft mit beschränkter Haftung (GMBH), Erlangen, Germany). It consists in a programmable stimulation unit connected to two titan ear electrodes that are mounted on a gel frame, allowing to generate and transfer electric impulses from the stimulation unit to the surface of the skin, where the electrodes are applied.

Trial Locations (1)

23842

Scientific Institute, IRCCS E. Medea, Bosisio Parini

All Listed Sponsors
collaborator

"IRCCS National Neurological Institute C. Mondino Foundation"

OTHER

collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

lead

IRCCS Eugenio Medea

OTHER

NCT06372028 - Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) | Biotech Hunter | Biotech Hunter