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Cortical Excitability Assessment Using Paired Pulses

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02245061
Acronym
PP
Enrollment
60
Registered
2014-09-19
Start date
2014-09-09
Completion date
2021-09-30
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Epilepsy

Keywords

pharmacoresistant focal epilepsy, cortical excitability, paired pulses, TMS, SEEG, DES

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.

Interventions

OTHERpaired pulses cortical electrical stimulation

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Patient with contraindication for MRI scanning * Pregnancy * Prohibition on participation in other research, apart from any other non-interventional research

Design outcomes

Primary

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

MeasureTime frame
Presence of a difference of responses patterns between anatomic regions and/or lesion typebetween 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 stimulationsBetween Day 7 and 21 (End of the stereoelectroencephalographic recordings)

Countries

France

Contacts

Primary ContactSylvain RHEIMS, MD
sylvain.rheims@univ-lyon1.fr4 17 30 60 64

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026