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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

About this trial

This is an interventional treatment trial for Drug-resistant Focal Epilepsy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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