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

February 21, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires St Luc
        • Contact:
        • Contact:
          • Simone VESPA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: refractory epilepsy patients
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
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laryngeal motor evoked potential (LMEP)
Time Frame: the LMEP is recorded for 60 minutes from the moment the patient arrives to the clinic to perform the test
Characteristics of the laryngeal motor evoked potential Threshold : the mA of current output necessary for evoking the LMEP Latency : the time between the negative peak of the stimulation artifact and the first positive deflection of the LMEP Amplitude : the difference in μV between the lowest negative and the highest positive peak of the LMEP Duration : the time between the first positive deflection of LMEP and the return to the noise level Dose- response curve: the relation between increasing intensity of vagal nerve stimulation and amplitude of the LMEP
the LMEP is recorded for 60 minutes from the moment the patient arrives to the clinic to perform the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2018

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/07NOV/416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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