Optimization of the Parameters of Vagal Nerve Stimulation

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Other: EEG; Other: Choice of VNS set of parameters based on the lowest PLI

• Registration Number: NCT04693221
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2021-04-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-06-16
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	EEG	VNS therapy with randomly-set combination of parameters (similar to current practice)
Experimental	EEG	VNS therapy with set combination of parameters chosen based on the lowest phase lag index
Experimental	Choice of VNS set of parameters based on the lowest PLI	VNS therapy with set combination of parameters chosen based on the lowest phase lag index

Primary Outcome Measures

Name	Time	Method
Mean number of seizures per month	Change from baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
Score of depression	Change from baseline to 12 months	NDDI-E
Number of generalized seizures	Change from baseline to 12 months
Score of anxiety	Change from baseline to 12 months	GAD-7
Number of seizures with alteration of consciousness	Change from baseline to 12 months
Number of responders in each group	Change from baseline to 12 months
Score of quality of life	Change from baseline to 12 months	QUOLIE 31
Number of seizures with falls	Change from baseline to 12 months

Trial Locations

Locations (18)

Hôpital St Joseph St Luc; 🇫🇷 Lyon, FRA, France

Neuropediatrics department, CHU Angers; 🇫🇷 Angers, France

Clinical neurophysiology, CHU Dijon; 🇫🇷 Dijon, France

Neurology Department, CHU Bordeaux; 🇫🇷 Bordeaux, France

Epilepsy neurophysiopathology department, CHU Grenoble; 🇫🇷 Grenoble, France

Clinical neurophysiology, CHU Lille; 🇫🇷 Lille, France

HCL Lyon; 🇫🇷 Lyon, France

Neurosurgery Department, CHRU Nancy; 🇫🇷 Nancy, France

Department of clinical neurophysiology, Hôpital La Timone, APHM; 🇫🇷 Marseille, France

Neurosurgery Department, CHU Nantes; 🇫🇷 Nantes, France

Neurosurgery Department, APHP; 🇫🇷 Paris, France

Epileptology Department, CHU Rennes; 🇫🇷 Rennes, France

Neurophysiology Department; 🇫🇷 Paris, France

Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan; 🇫🇷 Toulouse, France

Neurology and clinical neurophysiology, CHU Bretonneau; 🇫🇷 Tours, France

Department of functional explorations of the nervous system, CHU; 🇫🇷 Amiens, France

Neurophysiology Department, CHU Rouen; 🇫🇷 Rouen, France

Neurology Department, CHU Strasbourg; 🇫🇷 Strasbourg, France