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Cortical Excitability Assessment Using Paired Pulses (PP)

Primary Purpose

Focal Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
paired pulses cortical electrical stimulation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Focal Epilepsy focused on measuring pharmacoresistant focal epilepsy, cortical excitability, paired pulses, TMS, SEEG, DES

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

Patient with contraindication for MRI scanning

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

Sites / Locations

  • Hôpital neurologique de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

paired pulses cortical electrical stimulation

Arm Description

Outcomes

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
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
Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations

Full Information

First Posted
September 9, 2014
Last Updated
October 22, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02245061
Brief Title
Cortical Excitability Assessment Using Paired Pulses
Acronym
PP
Official Title
Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2014 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
Keywords
pharmacoresistant focal epilepsy, cortical excitability, paired pulses, TMS, SEEG, DES

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
paired pulses cortical electrical stimulation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
paired pulses cortical electrical stimulation
Primary Outcome Measure Information:
Title
Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex
Description
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)
Time Frame
between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Secondary Outcome Measure Information:
Title
Presence of a difference of responses patterns between anatomic regions and/or lesion type
Time Frame
between Day 7 and 21 (End of the stereoelectroencephalographic recordings )
Title
Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations
Time Frame
Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain RHEIMS, MD
Phone
4 17 30 60 64
Ext
+33
Email
sylvain.rheims@univ-lyon1.fr
Facility Information:
Facility Name
Hôpital neurologique de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain RHEIMS, MD
Phone
4 17 30 60 64
Ext
+33
Email
sylvain.rheims@chu-lyon.fr

12. IPD Sharing Statement

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Cortical Excitability Assessment Using Paired Pulses

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