Clinical trial NCT04693221: Optimization of the Parameters of Vagal Nerve Stimulation
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
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy
vagal nerve stimulation
phase lag index
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean number of seizures per month
timeFrame: Change from baseline to 6 months
measure: Mean number of seizures per month
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Number of responders in each group
timeFrame: Change from baseline to 6 months
measure: Number of responders in each group
timeFrame: Change from baseline to 12 months
measure: Number of generalized seizures
timeFrame: Change from baseline to 6 months
measure: Number of generalized seizures
timeFrame: Change from baseline to 12 months
measure: Number of seizures with falls
timeFrame: Change from baseline to 6 months
measure: Number of seizures with falls
timeFrame: Change from baseline to 12 months
measure: Number of seizures with alteration of consciousness
timeFrame: Change from baseline to 6 months
measure: Number of seizures with alteration of consciousness
timeFrame: Change from baseline to 12 months
measure: Score of depression
timeFrame: Change from baseline to 6 months
measure: Score of depression
timeFrame: Change from baseline to 12 months
measure: Score of anxiety
timeFrame: Change from baseline to 6 months
measure: Score of anxiety
timeFrame: Change from baseline to 12 months
measure: Score of quality of life
timeFrame: Change from baseline to 6 months
measure: Score of quality of life
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital St Joseph St Luc
state: FRA
city: Amiens
country: France
facility: Department of functional explorations of the nervous system, CHU
city: Angers
country: France
facility: Neuropediatrics department, CHU Angers
city: Bordeaux
country: France
facility: Neurology Department, CHU Bordeaux
city: Dijon
country: France
facility: Clinical neurophysiology, CHU Dijon
city: Grenoble
country: France
facility: Epilepsy neurophysiopathology department, CHU Grenoble
city: Lille
country: France
facility: Clinical neurophysiology, CHU Lille
city: Lyon
country: France
facility: HCL Lyon
city: Marseille
country: France
facility: Department of clinical neurophysiology, Hôpital La Timone, APHM
city: Nancy
country: France
facility: Neurosurgery Department, CHRU Nancy
city: Nantes
country: France
facility: Neurosurgery Department, CHU Nantes
city: Paris
country: France
facility: Neurosurgery Department, APHP
city: Paris
country: France
facility: Neurophysiology Department
city: Rennes
country: France
facility: Epileptology Department, CHU Rennes
city: Rouen
country: France
facility: Neurophysiology Department, CHU Rouen
city: Strasbourg
country: France
facility: Neurology Department, CHU Strasbourg
city: Toulouse
country: France
facility: Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan
city: Tours
country: France
facility: Neurology and clinical neurophysiology, CHU Bretonneau
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References: