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Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies (COAG)

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thermocoagulation
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Paediatrics, epilepsy surgery, genetic mutation, focal seizures

Eligibility Criteria

18 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 month to 17 years old
  • focal drug-resistant epilepsy
  • small size lesion (1 or 2 gyri) or cryptogenic epilepsy
  • indication for EEG monitoring with depth electrodes during presurgical evaluation

Exclusion Criteria:

  • formal contraindication to surgery or anaesthesia
  • functional area or potentially large epileptic area
  • refusal to participate in the study
  • no health insurance coverage

Sites / Locations

  • Fondation Ophtalmologique Adolphe de RothschildRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thermocoagulation

Arm Description

Outcomes

Primary Outcome Measures

Number of children with a decrease of at least 50% of the seizure frequency

Secondary Outcome Measures

Full Information

First Posted
August 29, 2016
Last Updated
July 26, 2022
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02886650
Brief Title
Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies
Acronym
COAG
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
June 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. Study Description

Brief Summary
When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Paediatrics, epilepsy surgery, genetic mutation, focal seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thermocoagulation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Thermocoagulation
Intervention Description
Thermocoagulation During pre-surgical Invasive EEG Monitoring
Primary Outcome Measure Information:
Title
Number of children with a decrease of at least 50% of the seizure frequency
Time Frame
one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 month to 17 years old focal drug-resistant epilepsy small size lesion (1 or 2 gyri) or cryptogenic epilepsy indication for EEG monitoring with depth electrodes during presurgical evaluation Exclusion Criteria: formal contraindication to surgery or anaesthesia functional area or potentially large epileptic area refusal to participate in the study no health insurance coverage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence SALOMON, MD, PhD
Phone
0033148036431
Email
lsalomon@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde CHIPAUX, MD
Organizational Affiliation
Fondation OPH A de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence SALOMON, MD, PhD

12. IPD Sharing Statement

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Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies

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