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EpilepsyOPSTIMVAGNCT04693221

Optimization of the Parameters of Vagal Nerve Stimulation

A study testing Choice of VNS set of parameters based on the lowest PLI and EEG in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 18 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Epilepsy
What is being tested?
Choice of VNS set of parameters based on the lowest PLI and EEG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
18 sitesFrance
Study dates
16 Apr 2021to 12 Dec 2026
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Department of functional explorations of the nervous system, CHU

    Amiens, France, 80054

  • Neuropediatrics department, CHU Angers

    Angers, France, 49933

  • Neurology Department, CHU Bordeaux

    Bordeaux, France, 33000

  • Clinical neurophysiology, CHU Dijon

    Dijon, France, 21079

  • Epilepsy neurophysiopathology department, CHU Grenoble

    Grenoble, France, 38043

  • Clinical neurophysiology, CHU Lille

    Lille, France, 59037

  • HCL Lyon

    Lyon, France, 69003

  • Hôpital St Joseph St Luc

    Lyon, FRA, 69007

  • Department of clinical neurophysiology, Hôpital La Timone, APHM

    Marseille, France, 13885

  • Neurosurgery Department, CHRU Nancy

    Nancy, France, 54000

  • Neurosurgery Department, CHU Nantes

    Nantes, France, 44093

  • Neurosurgery Department, APHP

    Paris, France, 75013

  • Neurophysiology Department

    Paris, France, 75014

  • Epileptology Department, CHU Rennes

    Rennes, France, 35000

  • Neurophysiology Department, CHU Rouen

    Rouen, France, 76000

  • Neurology Department, CHU Strasbourg

    Strasbourg, France, 67098

  • Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan

    Toulouse, France, 31059

  • Neurology and clinical neurophysiology, CHU Bretonneau

    Tours, France, 37044

Other trials in France

About this study

Official title: 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.

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.

Conditions
Epilepsy
Being tested
Choice of VNS set of parameters based on the lowest PLI, EEG
Keywords
epilepsy, vagal nerve stimulation, phase lag index
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Choice of VNS set of parameters based on the lowest PLIOther

    Vagal nerve stimulation according to PLI results.

  • EEGOther

    Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.

Study groups in NCT04693221
Study groupRoleWhat they receive
ControlSham comparatorVNS therapy with randomly-set combination of parameters (similar to current practice)
Receives: Other: EEG
ExperimentalExperimentalVNS therapy with set combination of parameters chosen based on the lowest phase lag index
Receives: Other: Choice of VNS set of parameters based on the lowest PLI; Other: EEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean number of seizures per month

    Measured: Change from baseline to 6 months

  2. Mean number of seizures per month

    Measured: Change from baseline to 12 months

Secondary outcomes (14)

  1. Number of responders in each group

    Measured: Change from baseline to 6 months

  2. Number of responders in each group

    Measured: Change from baseline to 12 months

  3. Number of generalized seizures

    Measured: Change from baseline to 6 months

  4. Number of generalized seizures

    Measured: Change from baseline to 12 months

  5. Number of seizures with falls

    Measured: Change from baseline to 6 months

  6. Number of seizures with falls

    Measured: Change from baseline to 12 months

  7. Number of seizures with alteration of consciousness

    Measured: Change from baseline to 6 months

  8. Number of seizures with alteration of consciousness

    Measured: Change from baseline to 12 months

  9. Score of depression

    NDDI-E

    Measured: Change from baseline to 6 months

  10. Score of depression

    NDDI-E

    Measured: Change from baseline to 12 months

  11. Score of anxiety

    GAD-7

    Measured: Change from baseline to 6 months

  12. Score of anxiety

    GAD-7

    Measured: Change from baseline to 12 months

  13. Score of quality of life

    QUOLIE 31

    Measured: Change from baseline to 6 months

  14. Score of quality of life

    QUOLIE 31

    Measured: Change from baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start16 Apr 2021
  3. Primary completion13 Jun 2025
  4. Study completion12 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04693221
Sponsor's protocol ID
2020-05
Other IDs
2020-A02657-32
Acronym
OPSTIMVAG
Status last verified
Feb 2026
First submitted
31 Dec 2020
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Choice of VNS set of parameters based on the lowest PLI and EEG in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Mean number of seizures per month (time frame: Change from baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693221.

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 10 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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