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

Phase 1

• Conditions: Focal Epilepsy; Epilepsy; Epilepsies, Focal; Drug-resistant Focal Epilepsy; Drug Resistant
• Interventions: Procedure: Laser technology for intracerebral thermocoagulation

• Registration Number: NCT05198882
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-20
• Status Verified: 2022-07
• Study Start: 2022-07-04
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04
• Primary Completion: 2023-09-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LITT technology	Laser technology for intracerebral thermocoagulation	Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France