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

Epilepsy Clinical Trial

— NEURO-LARYNX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03851770
• Other study ID #: 2018/07NOV/416
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Riëm EL TAHRY, Prof
• Phone: +322 764 28 55
• Email: riem.eltahry[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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 .

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the LMEP is recorded for 60 minutes from the moment the patient arrives to the clinic to perform the test