Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy (EPILITT)
Primary Purpose
Drug-resistant Focal Epilepsy, Epilepsy, Epilepsies, Focal
Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Laser technology for intracerebral thermocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Drug-resistant Focal Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years and < 80 years
- Patient with a medically unbalanced partial epilepsy
- Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG
- Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery.
- Endorsement of the Multidisciplinary Meeting of Neuro-epileptology
- Patient affiliated with a social security scheme
- Patient who has signed prior, free and informed consent
Exclusion Criteria:
- Pharmacosensitive epilepsy
- Patient with poor adherence to medication, or with psychological disorders
- Patients under legal protection
- Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.)
- Anticoagulant and antiplatelet therapy underway, cannot be stopped.
- Severe and unbalanced psychiatric disorders
- Pregnant women. Women of childbearing age should use oral contraception throughout the study.
- Allergy to local anaesthetics / general anaesthesia
Sites / Locations
- Hôpital Pitié SalpêtrièreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LITT technology
Arm Description
Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Seizure freedom evaluated with Engel classification
Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification
Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
Number of seizure per patient
Evaluate the frequency of seizure
Number of patient with at least one seizure with complex partial seizure
Evaluate the intensity of seizure after treatment.
Number of patient at least one modification of anti-epileptic treatment
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
Electrophysiological epileptic efficacy
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
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.
Incidence of adverse events
Evaluate the clinical tolerance of the procedure.
Mean consumption of anti-epileptic drugs and epilepsy-related care
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
Evaluate the radiological epileptic efficacy of treatment
Full Information
NCT ID
NCT05198882
First Posted
December 6, 2021
Last Updated
October 3, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT05198882
Brief Title
Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
Acronym
EPILITT
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-resistant Focal Epilepsy, Epilepsy, Epilepsies, Focal, Focal Epilepsy, Drug Resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LITT technology
Arm Type
Experimental
Arm Description
Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
Intervention Type
Procedure
Intervention Name(s)
Laser technology for intracerebral thermocoagulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification
Description
To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
Time Frame
Day 30 post-operative
Secondary Outcome Measure Information:
Title
Seizure freedom evaluated with Engel classification
Description
Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
Time Frame
Post surgery : Month 1, Month 3, Month 6, Month 12
Title
Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification
Description
Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
Time Frame
Post surgery : Month 1, Month 3, Month 6, Month 12
Title
Number of seizure per patient
Description
Evaluate the frequency of seizure
Time Frame
Post surgery : Month 1, Month 3, Month 6, Month 12
Title
Number of patient with at least one seizure with complex partial seizure
Description
Evaluate the intensity of seizure after treatment.
Time Frame
Post surgery : Month 1, Month 3, Month 6, Month 12
Title
Number of patient at least one modification of anti-epileptic treatment
Description
Evaluation of clinical efficacy of treatment
Time Frame
Post surgery : Month 1, Month 3, Month 6, Month 12
Title
Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG
Description
Electrophysiological epileptic efficacy
Time Frame
Post surgery : Month 3, Month 6, Month 12
Title
Mean change neuropsychological scores
Description
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
Time Frame
Post surgery : Month 12
Title
Mean change in Quality of Life in Epilepsy (QOLIE-31) scores
Description
Evaluate the effect on quality of life by comparing the preoperative assessment with the postoperative assessments.
Time Frame
Post surgery : Month 6, Month 12
Title
Incidence of adverse events
Description
Evaluate the clinical tolerance of the procedure.
Time Frame
Day of surgery, Day 2, Day 7, Day 30 post-operative
Title
Mean consumption of anti-epileptic drugs and epilepsy-related care
Description
To assess the medico-economic impact of the treatment
Time Frame
Post surgery : Month 12
Title
Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI
Description
Evaluate the radiological epileptic efficacy of treatment
Time Frame
Month 1, Month 3, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years and < 80 years
Patient with a medically unbalanced partial epilepsy
Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG
Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery.
Endorsement of the Multidisciplinary Meeting of Neuro-epileptology
Patient affiliated with a social security scheme
Patient who has signed prior, free and informed consent
Exclusion Criteria:
Pharmacosensitive epilepsy
Patient with poor adherence to medication, or with psychological disorders
Patients under legal protection
Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.)
Anticoagulant and antiplatelet therapy underway, cannot be stopped.
Severe and unbalanced psychiatric disorders
Pregnant women. Women of childbearing age should use oral contraception throughout the study.
Allergy to local anaesthetics / general anaesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrand Mathon, MD
Phone
01 84 82 73 63
Email
bertrand.mathon@aphp.fr
Facility Information:
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Mathon, MD
Phone
01 84 82 73 63
Ext
+33
Email
bertrand.mathon@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
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