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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Characterization of Vagus nerve stimulation
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cliniques Universitaires St LucRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

refractory epilepsy patients

Arm 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

Outcomes

Primary Outcome Measures

Laryngeal motor evoked potential (LMEP)
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

Secondary Outcome Measures

Full Information

First Posted
February 21, 2019
Last Updated
February 21, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03851770
Brief Title
Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation in Epileptic Patients
Acronym
NEURO-LARYNX
Official Title
NEURO-LARYNX:Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
refractory epilepsy patients
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Characterization of Vagus nerve stimulation
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Laryngeal motor evoked potential (LMEP)
Description
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
Time Frame
the LMEP is recorded for 60 minutes from the moment the patient arrives to the clinic to perform the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riëm EL TAHRY, Prof
Phone
+322 764 28 55
Email
riem.eltahry@uclouvain.be
Facility Information:
Facility Name
Cliniques Universitaires St Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riem EL TAHRY, Prof.
Phone
+322764 28 55
Email
riem.eltahry@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Simone VESPA, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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