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Optimization of the Parameters of Vagal Nerve Stimulation (OPSTIMVAG)

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Choice of VNS set of parameters based on the lowest PLI
EEG
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, vagal nerve stimulation, phase lag index

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital St Joseph St LucRecruiting
  • Department of functional explorations of the nervous system, CHURecruiting
  • Neuropediatrics department, CHU AngersRecruiting
  • Neurology Department, CHU BordeauxRecruiting
  • Clinical neurophysiology, CHU DijonRecruiting
  • Epilepsy neurophysiopathology department, CHU GrenobleRecruiting
  • Clinical neurophysiology, CHU LilleRecruiting
  • HCL LyonRecruiting
  • Department of clinical neurophysiology, Hôpital La Timone, APHMRecruiting
  • Neurosurgery Department, CHRU NancyRecruiting
  • Neurosurgery Department, CHU NantesRecruiting
  • Neurosurgery Department, APHPRecruiting
  • Neurophysiology DepartmentRecruiting
  • Epileptology Department, CHU RennesRecruiting
  • Neurophysiology Department, CHU RouenRecruiting
  • Neurology Department, CHU StrasbourgRecruiting
  • Neurophysiological explorations, Hôpital Pierre Paul Riquet, PurpanRecruiting
  • Neurology and clinical neurophysiology, CHU BretonneauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean number of seizures per month
Mean number of seizures per month

Secondary Outcome Measures

Number of responders in each group
Number of responders in each group
Number of generalized seizures
Number of generalized seizures
Number of seizures with falls
Number of seizures with falls
Number of seizures with alteration of consciousness
Number of seizures with alteration of consciousness
Score of depression
NDDI-E
Score of depression
NDDI-E
Score of anxiety
GAD-7
Score of anxiety
GAD-7
Score of quality of life
QUOLIE 31
Score of quality of life
QUOLIE 31

Full Information

First Posted
December 31, 2020
Last Updated
April 23, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04693221
Brief Title
Optimization of the Parameters of Vagal Nerve Stimulation
Acronym
OPSTIMVAG
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
April 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, vagal nerve stimulation, phase lag index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
VNS therapy with randomly-set combination of parameters (similar to current practice)
Arm Title
Experimental
Arm Type
Experimental
Arm Description
VNS therapy with set combination of parameters chosen based on the lowest phase lag index
Intervention Type
Other
Intervention Name(s)
Choice of VNS set of parameters based on the lowest PLI
Intervention Description
Vagal nerve stimulation according to PLI results.
Intervention Type
Other
Intervention Name(s)
EEG
Intervention Description
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 Outcome Measure Information:
Title
Mean number of seizures per month
Time Frame
Change from baseline to 6 months
Title
Mean number of seizures per month
Time Frame
Change from baseline to 12 months
Secondary Outcome Measure Information:
Title
Number of responders in each group
Time Frame
Change from baseline to 6 months
Title
Number of responders in each group
Time Frame
Change from baseline to 12 months
Title
Number of generalized seizures
Time Frame
Change from baseline to 6 months
Title
Number of generalized seizures
Time Frame
Change from baseline to 12 months
Title
Number of seizures with falls
Time Frame
Change from baseline to 6 months
Title
Number of seizures with falls
Time Frame
Change from baseline to 12 months
Title
Number of seizures with alteration of consciousness
Time Frame
Change from baseline to 6 months
Title
Number of seizures with alteration of consciousness
Time Frame
Change from baseline to 12 months
Title
Score of depression
Description
NDDI-E
Time Frame
Change from baseline to 6 months
Title
Score of depression
Description
NDDI-E
Time Frame
Change from baseline to 12 months
Title
Score of anxiety
Description
GAD-7
Time Frame
Change from baseline to 6 months
Title
Score of anxiety
Description
GAD-7
Time Frame
Change from baseline to 12 months
Title
Score of quality of life
Description
QUOLIE 31
Time Frame
Change from baseline to 6 months
Title
Score of quality of life
Description
QUOLIE 31
Time Frame
Change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romain Carron
Phone
0672274154
Email
romain.carron@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Bartolomei
Phone
0491385829
Email
fabrice.bartolomei@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital St Joseph St Luc
City
Lyon
State/Province
FRA
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien Didelot
Email
adidelot@ch-stjoseph-stluc-lyon.fr
Facility Name
Department of functional explorations of the nervous system, CHU
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Szurhaj
Email
szurhaj.william@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Michel Lefranc
Email
lefranc.michel@chu-amiens.fr
Facility Name
Neuropediatrics department, CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Van Bogaert
Email
patrick.vanbogaert@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Matthieu Delon
Email
matthieu.delion@chu-angers.fr
Facility Name
Neurology Department, CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie De Montaudouin
Email
marie.demontaudouin@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Guillaume Penchet
Email
guillaume.penchet@chu-bordeaux.fr
Facility Name
Clinical neurophysiology, CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Lemesle
Email
martine.lemesle@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Catherine Cao
Email
catherine.cao@chu-dijon.fr
Facility Name
Epilepsy neurophysiopathology department, CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Kahane
Email
pkahane@chu-grenoble.fr
Facility Name
Clinical neurophysiology, CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Derambure
Email
philippe.derambure@chru-lille.fr
Facility Name
HCL Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Rheims
Email
sylvain.rheims@univ-lyon1.fr
First Name & Middle Initial & Last Name & Degree
Marc Guénot
Email
marc.guenot@chu-lyon.fr
Facility Name
Department of clinical neurophysiology, Hôpital La Timone, APHM
City
Marseille
ZIP/Postal Code
13885
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Carron
First Name & Middle Initial & Last Name & Degree
Fabrice Bartolomei
Email
fabrice.bartolomei@ap-hm.fr
Facility Name
Neurosurgery Department, CHRU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Colnat-Coulbois
Email
s.coulbois@chru-nancy.fr
Facility Name
Neurosurgery Department, CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Raoul
Email
sylvie.raoul@chu-nantes.fr
Facility Name
Neurosurgery Department, APHP
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Mathon
Email
bertrand.mathon@aphp.fr
Facility Name
Neurophysiology Department
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Gavaret
Email
m.gavaret@ghu-paris.fr
First Name & Middle Initial & Last Name & Degree
Marc Zanello
Email
m.zanello@ch-sainte-anne.fr
Facility Name
Epileptology Department, CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Biraben
Email
arnaud.biraben@univ-rennes1.fr
First Name & Middle Initial & Last Name & Degree
Claire Haegelen
Email
claire.haegelen@chu-rennes.fr
Facility Name
Neurophysiology Department, CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Chastan
Email
nathalie.chastan@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Stéphane Derrey
Email
stephane.derrey@chu-rouen.fr
Facility Name
Neurology Department, CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Hirsch
Email
edouard.hirsch@chru-strasbourg.fr
Facility Name
Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Valton
Email
valton.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Jean Christophe Sol
Email
sol.jc@chu-toulouse.fr
Facility Name
Neurology and clinical neurophysiology, CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Biberon
Email
j.biberon@chu-tours.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimization of the Parameters of Vagal Nerve Stimulation

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