NCT04693221Active, not recruiting
Optimization of the Parameters of Vagal Nerve Stimulation
Optimization of the Parameters of Vagal Nerve Stimulation in Pharmaco- Resistant Epileptic Patients Based on a Surface EEG Index of Functional Connectivity (PLI: Phase Lag Index): a Randomized Double-blind Multicenter Controlled Study.
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 31 Dec 2020
- Start date
- 16 Apr 2021
- Primary completion date
- 13 Jun 2025
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Epilepsy
- NCT number
- NCT04693221
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 16 Apr 2021 to the primary completion date, 13 Jun 2025
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Difficulty to read or understand the French language, or inability to understand the information regarding the study
- Total patient's IQ below 64
- Subject in exclusion period due to enrolment in another study
- Patient with postoperative left vocal cord paralysis
- Patient on VNS since more than 6 months
Who the study is looking for
- Male or female epileptic patients over 12 years of age
- Suffering from pharmaco-resistant epilepsy
- With newly implanted VNS Aspire SR device
- Surgery performed in the previous 6 months
- Electrode impedance should be within normal range ( \< 4000 Ohms)
- Auto-stim mode working properly
- Mean number of seizures of at least (average 4 (mean value) / months during the baseline period)
- Patient, parents or legally representatives who have given written informed consent to allow the study data collection and procedures
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of functional explorations of the nervous system, CHU Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Neuropediatrics department, CHU Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Neurology Department, CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Clinical neurophysiology, CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Epilepsy neurophysiopathology department, CHU Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Clinical neurophysiology, CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital St Joseph St Luc Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| HCL Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Department of clinical neurophysiology, Hôpital La Timone, APHM Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Neurosurgery Department, CHRU Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Neurosurgery Department, CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Neurophysiology Department Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Neurosurgery Department, APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Epileptology Department, CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Neurophysiology Department, CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Neurology Department, CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Neurology and clinical neurophysiology, CHU Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.