- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02886650
Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies (COAG)
April 10, 2026 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 13 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Thermocoagulation
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Thermocoagulation During pre-surgical Invasive EEG Monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of children with a decrease of at least 50% of the seizure frequency
Time Frame: one month after surgery
|
one month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mathilde CHIPAUX, MD, Fondation OPH A de Rothschild
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
March 28, 2023
Study Completion (Actual)
May 28, 2024
Study Registration Dates
First Submitted
August 29, 2016
First Submitted That Met QC Criteria
August 29, 2016
First Posted (Estimated)
September 1, 2016
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCX_2015_31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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