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

Last updated: February 21, 2019
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT03851770
2018/07NOV/416
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • presence of a concomitant laryngeal pathology or RLN damage, independent from vagusnerve stimulation

  • important side effects of the VNS reported by the patient such as dyspnea, pain inneck/ear region and gastrointestinal complaints.

Study Design

Total Participants: 10
Study Start date:
December 27, 2018
Estimated Completion Date:
September 30, 2019

Connect with a study center

  • Cliniques Universitaires St Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

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