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

Epilepsy Clinical Trial

— EPISTIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844374
• Other study ID #: 38RC14.079
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 25, 2016
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Grenoble
• Contact: Philippe Kahane, Professor
• Phone: 04.76.76.54.48
• Email: philippe.kahane[@]ujf-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria :

• Patient from 5 to 65 years (L1121-7 L1122 2 CSP), including legally protected or unable to give his consent (L1121-8 CSP).

• Written approval of inclusion in the study from the patient or his legal representative.

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

Exclusion Criteria :

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Functional stereotaxic exploration
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.

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analysis	Visual analysis : in order to define the level of cortical resections.	up to one hour	No
Primary	Epileptogenic maps	Epileptogenic maps : calculated for each crisis and for all crisis in general.	up to 10 min	No
Primary	Connectivity maps	Connectivity maps : calculated for each site stimulated at low-frequency.	up to 10 min	No
Primary	MRI	Post-operative evaluation : in order to assess the extent of resection. MRI : 3D-T1	up to one hour	No