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Not yet recruitingNCT07904039Updated Oct 29, 2026

Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients

An interventional study of Increasing VNS Intensities Induced with Magnet in Refractory Epilepsy and Epilepsy, sponsored by Université Catholique de Louvain. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Basic science

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Refractory Epilepsy
  • Epilepsy
03

In context

Drug Resistant Epilepsy

275 studies on the registry are indexed under Drug Resistant Epilepsy; 104 are open to participants now.

This study's planned enrollment of 110 is above the median of 30 across 217 interventional studies indexed under Drug Resistant Epilepsy.

Browse Drug Resistant Epilepsy studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 152 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Patients aged ≥ 18 years old
  • IQ > 55 on Wechsler scale
  • Patients are diagnosed with refractory epilepsy and are candidates for VNS implantation or have it implanted for less than 2 weeks
  • Do not possess any laryngeal pathology nor any other neurological disease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    VNS Implanted Group

    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.

    Device: Increasing VNS Intensities Induced with Magnet

Interventions

  • DeviceIncreasing VNS Intensities Induced with Magnet

    Acute delivery of vagus nerve stimulation at increasing output intensity to evaluate and characterise laryngeal motor evoked potentials (LMEPs).

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Throughout the entire study, during approximately 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.

Of 96 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 75. This study's planned 36 months is close to that.

Counting every sponsor, half of 108 studies reached it within 34 months; a quarter within 20 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Jan 1, 2030
CompletionEst.
May 1, 2030
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904039
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
May 1, 2030 (estimated)
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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