Cortical Excitability Assessment Using Paired Pulses

NCT ID: NCT02245061

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-09

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Focal Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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paired pulses cortical electrical stimulation

Group Type EXPERIMENTAL

paired pulses cortical electrical stimulation

Intervention Type OTHER

Interventions

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paired pulses cortical electrical stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HĂ´pital neurologique de Lyon

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sylvain RHEIMS, MD

Role: CONTACT

4 17 30 60 64 ext. +33

Facility Contacts

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Sylvain RHEIMS, MD

Role: primary

4 17 30 60 64 ext. +33

Other Identifiers

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2014-A00495-42

Identifier Type: OTHER

Identifier Source: secondary_id

2014.865

Identifier Type: -

Identifier Source: org_study_id

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