Refractory EpilepsyNCT07904039
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
A study testing Increasing VNS Intensities Induced with Magnet in people with Refractory Epilepsy and Epilepsy, run by Université Catholique de Louvain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy, Epilepsy
- What is being tested?
- Increasing VNS Intensities Induced with Magnet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
About this study
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.
- Conditions
- Refractory Epilepsy, Epilepsy
- Being tested
- Increasing VNS Intensities Induced with Magnet
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing VNS Intensities Induced with MagnetDevice
Acute delivery of vagus nerve stimulation at increasing output intensity to evaluate and characterise laryngeal motor evoked potentials (LMEPs).
| Study group | Role | What they receive |
|---|---|---|
| VNS Implanted Group | Experimental | 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. Receives: Device: Increasing VNS Intensities Induced with Magnet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Throughout the entire study, during approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will receive the same stimulation intensities (except if maximum tolerance is reached) but will further be classified according to their clinical response to VNS.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904039
- Sponsor's protocol ID
- LONG-LMEP
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
- ClinicalTrials.gov ID
- NCT07904039
- Acronym / sponsor ID
- LONG-LMEP
- Conditions
- Refractory Epilepsy, Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will receive the same stimulation intensities (except if maximum tolerance is reached) but will further be classified according to their clinical response to VNS.
| Arm | Type | Receives |
|---|---|---|
| VNS Implanted Group | Experimental | Device: Increasing VNS Intensities Induced with MagnetPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increasing VNS Intensities Induced with MagnetAcute delivery of vagus nerve stimulation at increasing output intensity to evaluate and characterise laryngeal motor evoked potentials (LMEPs). | Device | VNS Implanted Group |
Primary outcome
Laryngeal Motor Evoked Potentials (LMEP)
Time frame: Throughout the entire study, during approximately 36 months
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing VNS Intensities Induced with Magnet in people with Refractory Epilepsy and Epilepsy, run by Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngeal Motor Evoked Potentials (LMEP) (time frame: Throughout the entire study, during approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.