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Active, Not Recruiting

NCT Number: NCT04693221

Optimization of the Parameters of Vagal Nerve Stimulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital St Joseph St Luc, Lyon, FRA, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Choice of VNS set of parameters based on the lowest PLI

Other

Vagal nerve stimulation according to PLI results.

EEG

Other

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.

Primary outcomes

  1. Mean number of seizures per month

    Time frame: Change from baseline to 6 months

  2. Mean number of seizures per month

    Time frame: Change from baseline to 12 months

Secondary outcomes

  1. Number of responders in each group

    Time frame: Change from baseline to 6 months

  2. Number of responders in each group

    Time frame: Change from baseline to 12 months

  3. Number of generalized seizures

    Time frame: Change from baseline to 6 months

  4. Number of generalized seizures

    Time frame: Change from baseline to 12 months

  5. Number of seizures with falls

    Time frame: Change from baseline to 6 months

  6. Number of seizures with falls

    Time frame: Change from baseline to 12 months

  7. Number of seizures with alteration of consciousness

    Time frame: Change from baseline to 6 months

  8. Number of seizures with alteration of consciousness

    Time frame: Change from baseline to 12 months

  9. Score of depression

    Time frame: Change from baseline to 6 months

    NDDI-E

  10. Score of depression

    Time frame: Change from baseline to 12 months

    NDDI-E

  11. Score of anxiety

    Time frame: Change from baseline to 6 months

    GAD-7

  12. Score of anxiety

    Time frame: Change from baseline to 12 months

    GAD-7

  13. Score of quality of life

    Time frame: Change from baseline to 6 months

    QUOLIE 31

  14. Score of quality of life

    Time frame: Change from baseline to 12 months

    QUOLIE 31

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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.

Acronym: OPSTIMVAG

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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