PP: Cortical Excitability Assessment Using Paired Pulses

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02245061

Collaborator

(none)

Enrollment

Location

Arm

84.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Focal Epilepsy	Other: paired pulses cortical electrical stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography

Actual Study Start Date :

Sep 9, 2014

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: paired pulses cortical electrical stimulation	Other: paired pulses cortical electrical stimulation

Arm

Intervention/Treatment

Experimental: paired pulses cortical electrical stimulation

Other: paired pulses cortical electrical stimulation

Outcome Measures

Primary Outcome Measures

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

Presence of a difference of responses patterns between anatomic regions and/or lesion type [between Day 7 and 21 (End of the stereoelectroencephalographic recordings )]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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