Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05198882
Other study ID # APHP200097
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 4, 2022
Est. completion date August 15, 2024

Study information

Verified date July 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Bertrand Mathon, MD
Phone 01 84 82 73 63
Email bertrand.mathon@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 13
Est. completion date August 15, 2024
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age =18 years and < 80 years 2. Patient with a medically unbalanced partial epilepsy 3. Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG 4. Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery. 5. Endorsement of the Multidisciplinary Meeting of Neuro-epileptology 6. Patient affiliated with a social security scheme 7. Patient who has signed prior, free and informed consent Exclusion Criteria: 1. Pharmacosensitive epilepsy 2. Patient with poor adherence to medication, or with psychological disorders 3. Patients under legal protection 4. Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.) 5. Anticoagulant and antiplatelet therapy underway, cannot be stopped. 6. Severe and unbalanced psychiatric disorders 7. Pregnant women. Women of childbearing age should use oral contraception throughout the study. 8. Allergy to local anaesthetics / general anaesthesia

Study Design


Intervention

Procedure:
Laser technology for intracerebral thermocoagulation
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.

Locations

Country Name City State
France Hôpital Pitié Salpêtrière Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Seizure freedom evaluated with Engel classification Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications. Post surgery : Month 1, Month 3, Month 6, Month 12
Secondary Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications. Post surgery : Month 1, Month 3, Month 6, Month 12
Secondary Number of seizure per patient Evaluate the frequency of seizure Post surgery : Month 1, Month 3, Month 6, Month 12
Secondary Number of patient with at least one seizure with complex partial seizure Evaluate the intensity of seizure after treatment. Post surgery : Month 1, Month 3, Month 6, Month 12
Secondary Number of patient at least one modification of anti-epileptic treatment Evaluation of clinical efficacy of treatment Post surgery : Month 1, Month 3, Month 6, Month 12
Secondary 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 Post surgery : Month 3, Month 6, Month 12
Secondary 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 Post surgery : Month 12
Secondary 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. Post surgery : Month 6, Month 12
Secondary Incidence of adverse events Evaluate the clinical tolerance of the procedure. Day of surgery, Day 2, Day 7, Day 30 post-operative
Secondary Mean consumption of anti-epileptic drugs and epilepsy-related care To assess the medico-economic impact of the treatment Post surgery : Month 12
Secondary 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 Month 1, Month 3, Month 12
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A