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

NCT02886650 | Completed

• 1 other identifier: MCX_2015_31
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Paediatrics; epilepsy surgery; genetic mutation; focal seizures

Outcome Measures

Primary Outcomes (1)

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

  one month after surgery

Study Arms (1)

Thermocoagulation

EXPERIMENTAL

Procedure: Thermocoagulation

Interventions

Thermocoagulation PROCEDURE

Thermocoagulation During pre-surgical Invasive EEG Monitoring

Thermocoagulation

Eligibility Criteria

• Age: 18 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Chipaux M, Taussig D, Dorfmuller G, Dorison N, Tisdall MM, Boyd SG, Thornton R, Eltze C, Fohlen M, Cross HJ, Ferrand-Sorbets S. SEEG-guided radiofrequency thermocoagulation of epileptic foci in the paediatric population: Feasibility, safety and efficacy. Seizure. 2019 Aug;70:63-70. doi: 10.1016/j.seizure.2019.07.004. Epub 2019 Jul 3.

  PMID: 31288205 RESULT

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mathilde CHIPAUX, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: December 1, 2015
• Primary Completion: March 28, 2023
• Study Completion: May 28, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

FR (1)