Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation.

NCT02844374 | Unknown

• 1 other identifier: 38RC14.079
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population. Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy. It is in this context that EPISTIM is interesting, and its aims isb a better electrophysiology delimiting of cortical networks that imply the genesis of seizures with the aim to improove surgery results. This study will rely on the intracerebral records and on corticales electrical stimulation as they are currently routinely used by epileptic patients candidates for surgery.

Conditions

Epilepsy

Keywords

Epilepsy; Surgery candidate; EEG's Signal

Outcome Measures

Primary Outcomes (4)

• Visual analysis

  Visual analysis : in order to define the level of cortical resections.

  up to one hour

• Epileptogenic maps

  Epileptogenic maps : calculated for each crisis and for all crisis in general.

  up to 10 min

• Connectivity maps

  Connectivity maps : calculated for each site stimulated at low-frequency.

  up to 10 min

• MRI

  Post-operative evaluation : in order to assess the extent of resection. MRI : 3D-T1

  up to one hour

Study Arms (1)

Partial Epilepsy Drug Resistant

OTHER

Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.

Other: Functional stereotaxic exploration

Interventions

Functional stereotaxic exploration OTHER

Visual analysis : in order to define the level of cortical resections. Epileptogenic maps : calculated for each crisis and for all crisis in general. Connectivity maps : calculated for each site stimulated at low-frequency. Post-operative evaluation : in order to assess the extent of resection.

Also known as: sEEG

Partial Epilepsy Drug Resistant

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient from 5 to 65 years (L1121-7 L1122 2 CSP), including legally protected or unable to give his consent (L1121-8 CSP).
• Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.

You may not qualify if:

• Patient under 5 years.
• Patient over 65 years.
• Pregnant or breastfeeeding women (L1121-5 CSP).
• Patient deprived of liberty as a result of a judicial or administrative decision (L1121-6 CSP).
• Patients over 18 years unable to give their free consent and not subject to a legal protection order.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Philippe Kahane, Professor

  Grenoble Hospital University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Kahane, Professor

CONTACT

04.76.76.54.48; philippe.kahane@ujf-grenoble.fr

Lorella Minotti, Hospital Practitioner

CONTACT

0476765448; Lminotti@chu-grenoble.fr

Study Design

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

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 26, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

FR (1)