Cortical Excitability Assessment Using Paired Pulses (PP)

October 22, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hôpital Neurologique de Lyon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
between Day 7 and 21 (End of the stereoelectroencephalographic recordings)

Secondary Outcome Measures

Outcome Measure
Time Frame
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 )
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
Time Frame: Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2014

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.865
  • 2014-A00495-42 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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