Clinical trial NCT03738072: Intracerebral Electrical Stimulation and the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy
Official title: A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Electrical Brain stimulation
Neurosurgery
stereo-electro-encephalography (SEEG)
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

Detailed description: Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. However the efficiency of these stimulations can be questioned and could potentially be improved. Indeed, only two typical frequencies are commonly used in our epilepsy centre, 1Hz and 50Hz, without clear clinical or scientific justification for these specific frequencies.

This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. We will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). The choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe).

The protocol will be proposed to all patients undergoing a stereo-electro-encephalography (SEEG) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. The efficiency will be assessed as any epileptic event, recorded in the intracerebral EEG or symptom induced by the stimulations. This project will last 36 months. 20 patients will be included.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old.

Exclusion Criteria:

* usual excluding criteria for a SEEG.

Primary outcomes:
measure: Comparison of the index of efficient stimulation between standard clinical stimulation condition and StiMic stimulation condition
timeFrame: 22 days after implantation of electrode
Secondary outcomes:
measure: efficient stimulation for each frequency of stimulation
timeFrame: 22 days after implantation of electrode
measure: efficient stimulation for each type of brain area stimulated
timeFrame: 22 days after implantation of electrode
measure: percentage change in the neuronal discharge rate
timeFrame: 30 second after stimulation
measure: percentage change in the neuronal discharge rate for stimic stimulation condition
timeFrame: 30 second after stimulation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU of Toulouse
name: Jonathan Curot, MD
role: PRINCIPAL_INVESTIGATOR
References: