Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation in Epileptic Patients (NEURO-LARYNX)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Epilepsy

Treatments: Other: Characterization of Vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03851770

2018/07NOV/416

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged between 18 and 65 years
• Vagus nerve stimulation implanted for at least 6 months
• No impedance issues with the VNS electrode

Exclusion criteria

• presence of a concomitant laryngeal pathology or RLN damage, independent from vagus nerve stimulation
• important side effects of the VNS reported by the patient such as dyspnea, pain in neck/ear region and gastrointestinal complaints.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

refractory epilepsy patients

Other group

Description:

All patients belong to the refractory epilepsy group. Intervention: Characterization of Vagus nerve stimulation: Evoked potentials (EP) are recorded using an EEG/EP digital acquisition system

Treatment:

Other: Characterization of Vagus nerve stimulation