Optimization of the Parameters of Vagal Nerve Stimulation

Epilepsy Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693221
• Other study ID #: 2020-05
• Secondary ID: 2020-A02657-32
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: April 4, 2026

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Romain Carron
• Phone: 0672274154
• Email: romain.carron[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 4, 2026
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Choice of VNS set of parameters based on the lowest PLI
Vagal nerve stimulation according to PLI results.
• EEG
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.

Locations

Country	Name	City	State
France	Department of functional explorations of the nervous system, CHU	Amiens
France	Neuropediatrics department, CHU Angers	Angers
France	Neurology Department, CHU Bordeaux	Bordeaux
France	Clinical neurophysiology, CHU Dijon	Dijon
France	Epilepsy neurophysiopathology department, CHU Grenoble	Grenoble
France	Clinical neurophysiology, CHU Lille	Lille
France	HCL Lyon	Lyon
France	Hôpital St Joseph St Luc	Lyon	FRA
France	Department of clinical neurophysiology, Hôpital La Timone, APHM	Marseille
France	Neurosurgery Department, CHRU Nancy	Nancy
France	Neurosurgery Department, CHU Nantes	Nantes
France	Neurophysiology Department	Paris
France	Neurosurgery Department, APHP	Paris
France	Epileptology Department, CHU Rennes	Rennes
France	Neurophysiology Department, CHU Rouen	Rouen
France	Neurology Department, CHU Strasbourg	Strasbourg
France	Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan	Toulouse
France	Neurology and clinical neurophysiology, CHU Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of seizures per month		Change from baseline to 6 months
Primary	Mean number of seizures per month		Change from baseline to 12 months
Secondary	Number of responders in each group		Change from baseline to 6 months
Secondary	Number of responders in each group		Change from baseline to 12 months
Secondary	Number of generalized seizures		Change from baseline to 6 months
Secondary	Number of generalized seizures		Change from baseline to 12 months
Secondary	Number of seizures with falls		Change from baseline to 6 months
Secondary	Number of seizures with falls		Change from baseline to 12 months
Secondary	Number of seizures with alteration of consciousness		Change from baseline to 6 months
Secondary	Number of seizures with alteration of consciousness		Change from baseline to 12 months
Secondary	Score of depression	NDDI-E	Change from baseline to 6 months
Secondary	Score of depression	NDDI-E	Change from baseline to 12 months
Secondary	Score of anxiety	GAD-7	Change from baseline to 6 months
Secondary	Score of anxiety	GAD-7	Change from baseline to 12 months
Secondary	Score of quality of life	QUOLIE 31	Change from baseline to 6 months
Secondary	Score of quality of life	QUOLIE 31	Change from baseline to 12 months