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Trial record 3 of 48 for:    vagus nerve stimulation | Epilepsy
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Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation in Epileptic Patients (NEURO-LARYNX)

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ClinicalTrials.gov Identifier: NCT03851770
Recruitment Status : Unknown
Verified February 2019 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Characterization of Vagus nerve stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients participating will be asked to come to the Neurophysiology Department of Saint Luc Clinic to peform the laryngeal evoked motor potential.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: NEURO-LARYNX:Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
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 .


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851770


Contacts
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Contact: Riëm EL TAHRY, Prof +322 764 28 55 riem.eltahry@uclouvain.be

Locations
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Belgium
Cliniques Universitaires St Luc Recruiting
Brussels, Belgium, 1200
Contact: Riem EL TAHRY, Prof.    +322764 28 55    riem.eltahry@uclouvain.be   
Contact: Simone VESPA, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03851770    
Other Study ID Numbers: 2018/07NOV/416
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases