Cortical Excitability Assessment Using Paired Pulses

Focal Epilepsy Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02245061
• Other study ID #: 2014.865
• Secondary ID: 2014-A00495-42
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2014
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: Sylvain RHEIMS, MD
• Phone: 4 17 30 60 64
• Email: sylvain.rheims[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Intervention

Other:
• paired pulses cortical electrical stimulation

Locations

Country	Name	City	State
France	Hôpital neurologique de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Secondary	Presence of a difference of responses patterns between anatomic regions and/or lesion type		between Day 7 and 21 (End of the stereoelectroencephalographic recordings )
Secondary	Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations		Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)