Cortical Excitability Assessment Using Paired Pulses

NCT02245061 | Unknown

• 2 other identifiers: 2014.8652014-A00495-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Epilepsy

Keywords

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

Outcome Measures

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)

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

Secondary Outcomes (2)

• Presence of a difference of responses patterns between anatomic regions and/or lesion type

  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

  Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)

Study Arms (1)

paired pulses cortical electrical stimulation

EXPERIMENTAL

Other: paired pulses cortical electrical stimulation

Interventions

paired pulses cortical electrical stimulation OTHER

paired pulses cortical electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital neurologique de Lyon

Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sylvain RHEIMS, MD

CONTACT

4 17 30 60 64; sylvain.rheims@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 19, 2014
• Study Start: September 9, 2014
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

FR (1)