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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Focal Epilepsy; Drug Resistant; Drug-resistant Focal Epilepsy; Epilepsies, Focal
• Intervention / Treatment: Procedure: Laser technology for intracerebral thermocoagulation

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bertrand Mathon, MD; Phone Number: 01 84 82 73 63; Email: bertrand.mathon@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hopital Pitie Salpetriere
    • Contact: Bertrand Mathon, MD; Phone Number: +33 01 84 82 73 63; Email: bertrand.mathon@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years and < 80 years
2. Patient with a medically unbalanced partial epilepsy
3. Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG
4. Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery.
5. Endorsement of the Multidisciplinary Meeting of Neuro-epileptology
6. Patient affiliated with a social security scheme
7. Patient who has signed prior, free and informed consent

Exclusion Criteria:

1. Pharmacosensitive epilepsy
2. Patient with poor adherence to medication, or with psychological disorders
3. Patients under legal protection
4. Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.)
5. Anticoagulant and antiplatelet therapy underway, cannot be stopped.
6. Severe and unbalanced psychiatric disorders
7. Pregnant women. Women of childbearing age should use oral contraception throughout the study.
8. Allergy to local anaesthetics / general anaesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: LITT technology; Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.

Procedure: Laser technology for intracerebral thermocoagulation; One intervention : LITT (Laser Interstitial Thermal Treatment), technology that uses laser energy to thermally destroy (photo-thermal treatment) a brain injury under continuous MRI control (Validated by FDA - CE marking). The operator console + surgical laser generator + software that manages the power delivered by the laser is connected to an MRI - Provided by MEDTRONIC - FDA approved and CE certified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification	To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.	Day 30 post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure freedom evaluated with Engel classification	Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.	Post surgery : Month 1, Month 3, Month 6, Month 12
Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification	Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.	Post surgery : Month 1, Month 3, Month 6, Month 12
Number of seizure per patient	Evaluate the frequency of seizure	Post surgery : Month 1, Month 3, Month 6, Month 12
Number of patient with at least one seizure with complex partial seizure	Evaluate the intensity of seizure after treatment.	Post surgery : Month 1, Month 3, Month 6, Month 12
Number of patient at least one modification of anti-epileptic treatment	Evaluation of clinical efficacy of treatment	Post surgery : Month 1, Month 3, Month 6, Month 12
Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG	Electrophysiological epileptic efficacy	Post surgery : Month 3, Month 6, Month 12
Mean change neuropsychological scores	Evaluate the effect on cognition by a postoperative neuropsychological evaluation, compared with the pre-treatment neuropsychological evaluation.The neuro-psychological test will be selected according to the location of the lesion/focus	Post surgery : Month 12
Mean change in Quality of Life in Epilepsy (QOLIE-31) scores	Evaluate the effect on quality of life by comparing the preoperative assessment with the postoperative assessments.	Post surgery : Month 6, Month 12
Incidence of adverse events	Evaluate the clinical tolerance of the procedure.	Day of surgery, Day 2, Day 7, Day 30 post-operative
Mean consumption of anti-epileptic drugs and epilepsy-related care	To assess the medico-economic impact of the treatment	Post surgery : Month 12
Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI	Evaluate the radiological epileptic efficacy of treatment	Month 1, Month 3, Month 12

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Anticipated): September 15, 2023
• Study Completion (Anticipated): August 15, 2024

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: APHP200097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No