Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy (EPILITT)
3. oktober 2022 opdateret af: Assistance Publique - Hôpitaux de Paris
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
13
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bertrand Mathon, MD
- Telefonnummer: 01 84 82 73 63
- E-mail: bertrand.mathon@aphp.fr
Studiesteder
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-
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Paris, Frankrig, 75013
- Rekruttering
- Hôpital Pitie Salpétrière
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Kontakt:
- Bertrand Mathon, MD
- Telefonnummer: +33 01 84 82 73 63
- E-mail: bertrand.mathon@aphp.fr
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: LITT technology
Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification
Tidsramme: Day 30 post-operative
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To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
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Day 30 post-operative
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Seizure freedom evaluated with Engel classification
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Number of seizure per patient
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the frequency of seizure
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Number of patient with at least one seizure with complex partial seizure
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the intensity of seizure after treatment.
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Number of patient at least one modification of anti-epileptic treatment
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluation of clinical efficacy of treatment
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG
Tidsramme: Post surgery : Month 3, Month 6, Month 12
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Electrophysiological epileptic efficacy
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Post surgery : Month 3, Month 6, Month 12
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Mean change neuropsychological scores
Tidsramme: Post surgery : Month 12
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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
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Post surgery : Month 12
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Mean change in Quality of Life in Epilepsy (QOLIE-31) scores
Tidsramme: Post surgery : Month 6, Month 12
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Evaluate the effect on quality of life by comparing the preoperative assessment with the postoperative assessments.
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Post surgery : Month 6, Month 12
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Incidence of adverse events
Tidsramme: Day of surgery, Day 2, Day 7, Day 30 post-operative
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Evaluate the clinical tolerance of the procedure.
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Day of surgery, Day 2, Day 7, Day 30 post-operative
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Mean consumption of anti-epileptic drugs and epilepsy-related care
Tidsramme: Post surgery : Month 12
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To assess the medico-economic impact of the treatment
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Post surgery : Month 12
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Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI
Tidsramme: Month 1, Month 3, Month 12
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Evaluate the radiological epileptic efficacy of treatment
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Month 1, Month 3, Month 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. juli 2022
Primær færdiggørelse (Forventet)
15. september 2023
Studieafslutning (Forventet)
15. august 2024
Datoer for studieregistrering
Først indsendt
6. december 2021
Først indsendt, der opfyldte QC-kriterier
17. januar 2022
Først opslået (Faktiske)
20. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. oktober 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP200097
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