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Clinical Trials/NCT02245061
NCT02245061
Unknown
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country60 target enrollmentSeptember 9, 2014
ConditionsFocal Epilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Focal Epilepsy
Sponsor
Hospices Civils de Lyon
Enrollment
60
Locations
1
Primary Endpoint
Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2014
End Date
September 30, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex

Time Frame: 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 Outcomes

  • 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 ))

Study Sites (1)

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