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Clinical Trials/NCT02844374
NCT02844374UnknownNot Applicable

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

University Hospital, Grenoble2 sites in 1 country45 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
45
Locations
2
Primary Endpoint
Connectivity maps

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
5 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Connectivity maps

Time Frame: up to 10 min

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

Visual analysis

Time Frame: up to one hour

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

Epileptogenic maps

Time Frame: up to 10 min

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

MRI

Time Frame: up to one hour

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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