AzTrials
AzTrials

Drug-resistant Focal EpilepsyPhase 1EPILITTNCT05198882

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

A Phase 1 study testing Laser technology for intracerebral thermocoagulation in people with Drug-resistant Focal Epilepsy and Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Laser technology for intracerebral thermocoagulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteFrance
Study dates
4 Jul 2022to 15 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bertrand Mathon, MD contact

01 84 82 73 63

bertrand.mathon@aphp.fr

France1 site, 1 recruiting

  • Hôpital Pitié Salpêtrière

    Paris, 75013

    Bertrand Mathon, MD, 01 84 82 73 63 ext. +33, bertrand.mathon@aphp.fr

    Recruiting

Other trials in France

About this study

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.

Being tested
Laser technology for intracerebral thermocoagulation
Medical subject headings
Epilepsy, Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser technology for intracerebral thermocoagulationProcedure or surgery

    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.

Study groups in NCT05198882
Study groupRoleWhat they receive
LITT technologyExperimentalLaser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
Receives: Procedure: Laser technology for intracerebral thermocoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 30 post-operative

Secondary outcomes (11)

  1. Seizure freedom evaluated with Engel classification

    Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.

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

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

    Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.

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

  3. Number of seizure per patient

    Evaluate the frequency of seizure

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

  4. Number of patient with at least one seizure with complex partial seizure

    Evaluate the intensity of seizure after treatment.

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

  5. Number of patient at least one modification of anti-epileptic treatment

    Evaluation of clinical efficacy of treatment

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

  6. 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

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

  7. 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

    Measured: Post surgery : Month 12

  8. 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.

    Measured: Post surgery : Month 6, Month 12

  9. Incidence of adverse events

    Evaluate the clinical tolerance of the procedure.

    Measured: Day of surgery, Day 2, Day 7, Day 30 post-operative

  10. Mean consumption of anti-epileptic drugs and epilepsy-related care

    To assess the medico-economic impact of the treatment

    Measured: Post surgery : Month 12

  11. 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

    Measured: Month 1, Month 3, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start4 Jul 2022
  3. Primary completion15 Sep 2023 (estimated)
  4. Study completion15 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05198882
Sponsor's protocol ID
APHP200097
Acronym
EPILITT
Status last verified
Jul 2022
First submitted
6 Dec 2021
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laser technology for intracerebral thermocoagulation in people with Drug-resistant Focal Epilepsy and Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bertrand Mathon, MD (01 84 82 73 63, bertrand.mathon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification (time frame: Day 30 post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05198882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in