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

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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)

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

Trial contacts and locations

0

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Central trial contact

Riëm EL TAHRY, Prof

Data sourced from clinicaltrials.gov

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