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

NCT05198882 | Unknown Phase 1 DMC

• 1 other identifier: APHP200097
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-resistant Focal Epilepsy; Epilepsy; Epilepsies, Focal; Focal Epilepsy; Drug Resistant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Seizure freedom evaluated with Engel classification

  Post surgery : Month 1, Month 3, Month 6, Month 12

• Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification

  Post surgery : Month 1, Month 3, Month 6, Month 12

• Number of seizure per patient

  Post surgery : Month 1, Month 3, Month 6, Month 12

• Number of patient with at least one seizure with complex partial seizure

  Post surgery : Month 1, Month 3, Month 6, Month 12

• Number of patient at least one modification of anti-epileptic treatment

  Post surgery : Month 1, Month 3, Month 6, Month 12

Study Arms (1)

LITT technology

EXPERIMENTAL

Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.

Procedure: Laser technology for intracerebral thermocoagulation

Interventions

Laser technology for intracerebral thermocoagulation PROCEDURE

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.

LITT technology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Medtronic: collaborator

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Bertrand Mathon, MD

CONTACT

01 84 82 73 63; bertrand.mathon@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 20, 2022
• Study Start: July 4, 2022
• Primary Completion: September 15, 2023
• Study Completion: August 15, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-07

Locations

FR (1)