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

Epilepsy Clinical Trial

— COAG  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02886650
• Other study ID #: MCX_2015_31
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 11, 2024

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Laurence SALOMON, MD, PhD
• Phone: 0033148036431
• Email: lsalomon[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 11, 2024
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Procedure:
• Thermocoagulation
Thermocoagulation During pre-surgical Invasive EEG Monitoring

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children with a decrease of at least 50% of the seizure frequency		one month after surgery