Cortical Excitability Assessment Using Paired Pulses

Not Applicable

• Conditions: Focal Epilepsy
• Interventions: Other: paired pulses cortical electrical stimulation

• Registration Number: NCT02245061
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.

However, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.

The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age above 18 years old
• Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic recording
• Provide written consent to the study after receiving clear information
• Be a beneficiary or member of health insurance plan

Exclusion Criteria

Patient with contraindication for MRI scanning

• Pregnancy
• Prohibition on participation in other research, apart from any other non-interventional research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paired pulses cortical electrical stimulation	paired pulses cortical electrical stimulation	-

Primary Outcome Measures

Name	Time	Method
Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex	between Day 7 and 21 (End of the stereoelectroencephalographic recordings)	Low frequency single pulse electrical stimulation induces several cortico-cortical electroencephalographic responses: early-physiological and/or late-pathological. We expect different paired pulses modulation of those responses according the excitability level of the stimulated cortex (in terms of latency, amplitude, surface, frequency power)

Secondary Outcome Measures

Name	Time	Method
Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations	Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Presence of a difference of responses patterns between anatomic regions and/or lesion type	between Day 7 and 21 (End of the stereoelectroencephalographic recordings )

Trial Locations

Locations (1)

Hôpital neurologique de Lyon; 🇫🇷 Lyon, France