Status:
UNKNOWN
Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Medtronic
Conditions:
Drug-resistant Focal Epilepsy
Epilepsy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 necr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05198882
Start Date
July 4 2022
End Date
August 15 2024
Last Update
October 4 2022
Active Locations (1)
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1
Hôpital Pitié Salpêtrière
Paris, France, 75013