Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy — EPILITT  

Epilepsy Clinical Trial

Official title: Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy

Status Recruiting

Clinical Trial Summary

Laser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Drug Resistant
• Epilepsies, Focal
• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

• NCT number: NCT05198882
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bertrand Mathon, MD
• Phone: 01 84 82 73 63
• Email: bertrand.mathon@aphp.fr
• Status: Recruiting
• Phase: Phase 1
• Start date: July 4, 2022
• Completion date: August 15, 2024