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Status unknownNCT02245061PPUpdated Oct 23, 2019

Cortical Excitability Assessment Using Paired Pulses

An interventional study of paired pulses cortical electrical stimulation in Focal Epilepsy, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-23.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Focal Epilepsy

Keywords

  • pharmacoresistant focal epilepsy
  • cortical excitability
  • paired pulses
  • TMS
  • SEEG
  • DES
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

Patient with contraindication for MRI scanning

  • Pregnancy
  • Prohibition on participation in other research, apart from any other non-interventional research
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    paired pulses cortical electrical stimulation

    Other: paired pulses cortical electrical stimulation

Interventions

  • Otherpaired pulses cortical electrical stimulation
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings)

Secondary outcomes

  1. 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 )

  2. 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)

07

Study locations

1 of 1 sites recruiting
  • Hôpital neurologique de Lyon
    Lyon, 69003, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02245061
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 19, 2014
Start date
Sep 9, 2014
Primary completion
Sep 30, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Oct 23, 2019

Study contacts

Sylvain RHEIMS, MD
Contact
sylvain.rheims@univ-lyon1.fr
4 17 30 60 64 ext. +33

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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