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NOT YET RECRUITING
NCT07904039
NA

Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients

Sponsor: Université Catholique de Louvain

View on ClinicalTrials.gov

Summary

Although VNS has been widely used in clinic for over 30 years, its mechanisms of action remain unclear and there is a lack of individual biomarkers of efficacy. One potential and understudied source of variability on the response to VNS may be related to nerve function and recovery following implantation. VNS co-activates the recurrent laryngeal branch of the vagus nerve, which carries vagal-Aα fibres innervating all the laryngeal muscles except the cricothyroid. VNS-induced effective activation of the recurrent laryngeal nerve generates a so-called LMEP. Despite the fact that the LMEP represents a simple, non-invasive, and feasible technique to employ in clinical routine, it is not yet sufficiently investigated. This study comprises 5 visits (2 weeks, 1 month, 3 months, 6 months, and 12 months after VNS implantation) and consists of the measurement of the laryngeal-motor evoked potentials induced by vagus nerve stimulation (VNS), that will be further compared with the corresponding clinical response to VNS.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2027-01-01

Completion Date

2030-05-01

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DEVICE

Increasing VNS Intensities Induced with Magnet

Acute delivery of vagus nerve stimulation at increasing output intensity to evaluate and characterise laryngeal motor evoked potentials (LMEPs).