NCT07904039|Not Yet Recruiting
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Sponsor study identifier
interventional
110
0 countries
N/A
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Although VNS has been widely used in clinic for over 30 years, its mechanisms of action remain unclear and there is a lack of individual biomarkers of efficacy. One potential and understudied source of variability on the response to VNS may be related to nerve function and recovery following implantation. VNS co-activates the recurrent laryngeal branch of the vagus nerve, which carries vagal-Aα fibres innervating all the laryngeal muscles except the cricothyroid. VNS-induced effective activation of the recurrent laryngeal nerve generates a so-called LMEP. Despite the fact that the LMEP represents a simple, non-invasive, and feasible technique to employ in clinical routine, it is not yet sufficiently investigated. This study comprises 5 visits (2 weeks, 1 month, 3 months, 6 months, and 12 months after VNS implantation) and consists of the measurement of the laryngeal-motor evoked potentials induced by vagus nerve stimulation (VNS), that will be further compared with the corresponding clinical response to VNS.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2026
Actual (reported)October 29, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Laryngeal Motor Evoked Potentials (LMEP)
Peak amplitude of the laryngeal motor evoked potential (measured in microvolts, µV) and latency (time to peak, in seconds) recorded via surface electromyography (EMG) electrodes placed on the neck following vagus nerve stimulation (VNS).
Throughout the entire study, during approximately 36 months
Patients with refractory epilepsy who were recently implanted with a vagus nerve stimulation (VNS) device. Participants undergo recordings of laryngeal motor evoked potentials (LMEPs) with increasing VNS current intensities.
Acute delivery of vagus nerve stimulation at increasing output intensity to evaluate and characterise laryngeal motor evoked potentials (LMEPs).
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
First Submitted
October 22, 2026
First Posted
October 29, 2026
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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