Clinical trial NCT05198882: Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Drug-resistant Focal Epilepsy
Epilepsy
Epilepsies, Focal
Focal Epilepsy
Drug Resistant
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2022-01-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification
timeFrame: Day 30 post-operative
Secondary outcomes:
measure: Seizure freedom evaluated with Engel classification
timeFrame: Post surgery : Month 1, Month 3, Month 6, Month 12
measure: Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification
timeFrame: Post surgery : Month 1, Month 3, Month 6, Month 12
measure: Number of seizure per patient
timeFrame: Post surgery : Month 1, Month 3, Month 6, Month 12
measure: Number of patient with at least one seizure with complex partial seizure
timeFrame: Post surgery : Month 1, Month 3, Month 6, Month 12
measure: Number of patient at least one modification of anti-epileptic treatment
timeFrame: Post surgery : Month 1, Month 3, Month 6, Month 12
measure: Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG
timeFrame: Post surgery : Month 3, Month 6, Month 12
measure: Mean change neuropsychological scores
timeFrame: Post surgery : Month 12
measure: Mean change in Quality of Life in Epilepsy (QOLIE-31) scores
timeFrame: Post surgery : Month 6, Month 12
measure: Incidence of adverse events
timeFrame: Day of surgery, Day 2, Day 7, Day 30 post-operative
measure: Mean consumption of anti-epileptic drugs and epilepsy-related care
timeFrame: Post surgery : Month 12
measure: Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI
timeFrame: Month 1, Month 3, Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
References: