Optimization of the Parameters of Vagal Nerve Stimulation

NCT04693221 | Active Not Recruiting

• 2 other identifiers: 2020-052020-A02657-32
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 18

Brief 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. 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

Keywords

epilepsy; vagal nerve stimulation; phase lag index

Outcome Measures

Primary Outcomes (2)

• Mean number of seizures per month

  Change from baseline to 6 months

• Mean number of seizures per month

  Change from baseline to 12 months

Secondary Outcomes (14)

• Number of responders in each group

  Change from baseline to 6 months

• Number of responders in each group

  Change from baseline to 12 months

• Number of generalized seizures

  Change from baseline to 6 months

• Number of generalized seizures

  Change from baseline to 12 months

• Number of seizures with falls

  Change from baseline to 6 months

Study Arms (2)

Control

SHAM COMPARATOR

VNS therapy with randomly-set combination of parameters (similar to current practice)

Other: EEG

Experimental

EXPERIMENTAL

VNS therapy with set combination of parameters chosen based on the lowest phase lag index

Other: Choice of VNS set of parameters based on the lowest PLI; Other: EEG

Interventions

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.

Control; Experimental

Choice of VNS set of parameters based on the lowest PLI OTHER

Vagal nerve stimulation according to PLI results.

Experimental

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Difficulty to read or understand the French language, or inability to understand the information regarding the study
• Total patient's IQ below 64
• Patient with postoperative left vocal cord paralysis
• Patient on VNS since more than 6 months

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (18)

Department of functional explorations of the nervous system, CHU

Amiens, France, 80054, France

Location

Neuropediatrics department, CHU Angers

Angers, France, 49933, France

Location

Neurology Department, CHU Bordeaux

Bordeaux, France, 33000, France

Location

Clinical neurophysiology, CHU Dijon

Dijon, France, 21079, France

Location

Epilepsy neurophysiopathology department, CHU Grenoble

Grenoble, France, 38043, France

Location

Clinical neurophysiology, CHU Lille

Lille, France, 59037, France

Location

HCL Lyon

Lyon, France, 69003, France

Location

Department of clinical neurophysiology, Hôpital La Timone, APHM

Marseille, France, 13885, France

Location

Neurosurgery Department, CHRU Nancy

Nancy, France, 54000, France

Location

Neurosurgery Department, CHU Nantes

Nantes, France, 44093, France

Location

Neurosurgery Department, APHP

Paris, France, 75013, France

Location

Neurophysiology Department

Paris, France, 75014, France

Location

Epileptology Department, CHU Rennes

Rennes, France, 35000, France

Location

Neurophysiology Department, CHU Rouen

Rouen, France, 76000, France

Location

Neurology Department, CHU Strasbourg

Strasbourg, France, 67098, France

Location

Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan

Toulouse, France, 31059, France

Location

Neurology and clinical neurophysiology, CHU Bretonneau

Tours, France, 37044, France

Location

Hôpital St Joseph St Luc

Lyon, FRA, 69007, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: April 16, 2021
• Primary Completion: June 13, 2025
• Study Completion (Estimated): December 12, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)