NCT03851770

Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation in Epileptic Patients

NEURO-LARYNX:Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to record and characterize larynx evoked motor potentials induced by vagus nerve stimulation. This study will include 10 adult patients implanted with a Vagus nerve stimulator, followed at the Center for Refractory Epilepsy at Cliniques St Luc. The inclusion criteria are: (1) patient aged between 18 and 65 years ; (2) cervical VNS device (Cyberonics, Houston, TX, USA) implanted for at least 6 months, (3) normal electrode impedance of the electrode. Exclusion criteria are (1) presence of a concomitant laryngeal pathology or recurrent laryngeal nerve damage, independent from VNS ; (2) important VNS side effects reported by the patient, such as severe dyspnea (grade III-IV) or severe pain in the neck/ear region.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Characterization of Vagus nerve stimulation	Characterization of Vagus nerve stimulation induced larynx evoked motor potential. Patients participating in the study will be asked to come to perform the experiment (duration maximum 1 hour) at the Neurophysiology Department of Saint Luc .

Timeline

• Start date: 2018-12-27
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2019-02-22
• Last updated: 2019-02-22

Locations

1 site across 1 country: Belgium