Clinical trial NCT06341075: Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy
Official title: Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Patients With Drug-resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: MRgLITT
Drug-resistant Epilepsy
Seizure Control
Functional Preservation
Real-world STUDY
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE).

Detailed description: Epilepsy, a complex neurological disorder characterized by recurrent seizures, affects millions of individuals worldwide, challenging both patients and healthcare providers. The main indication for the epilepsy surgery is the drug resistance as per the consensus from the Task Force of the International League Against Epilepsy (ILAE). Traditional open surgery is an established treatment for drug-resistant epilepsy (DRE), but has limitations such as invasiveness and long recovery times. With the significant advancements of technology, the minimally invasive therapeutic approaches have emerged, among which Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) stands out as a promising intervention. It provides targeted ablation of epileptogenic tissue while preserving healthy brain regions. Understanding MRgLITT's comprehensive value for DRE is of increasing interest.

This real-world study aims to comprehensively evaluate the clinical outcomes, safety profiles, and cost-effectiveness of MRgLITT in patients with DRE. The results of this clinical trial protocol are expected to serve as a comprehensive guide for researchers, clinicians, and stakeholders interested in the treatment of DRE using MRgLITT. We believe this study can influence future treatment strategies, leading to improved outcomes and enhanced quality of life for individuals with epilepsy.

Eligibility criteria: Inclusion Criteria:

* Age between 12 and 75 (provided that rigorous prior studies have been done to suggest appropriate dosing for ages 12 and above);
* Patients or the assents are able to provide informed consent;
* Ability to keep accurate seizure diaries;
* Complete presurgical evaluation information;
* Meets the 2009 ILAE definition of DRE (Failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapy or in combination) to achieve sustained seizure freedom) ;

Exclusion Criteria:

* Subjects with significant progressive disorders or unstable medical conditions requiring acute intervention;
* Clinically relevant abnormalities in bloodwork detected (e.g., rising or new onset 3X liver function tests \[LFTs\]);
* Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt;
* A psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study;
* Diagnosed with intracranial space-occupying lesions or dual pathology by neuroimaging inspection;
* Women who are pregnant, planning to become pregnant during the study period, or currently breastfeeding may be excluded due to the potential risks associated with surgery and anesthesia;
* Patients with a history of previous brain surgery, including prior epilepsy surgery, that may interfere with the study objectives or confound the interpretation of results may be excluded;
* Any condition that may impact a patient's ability to follow study procedures or patient's safety, based on what is known about the pharmacology/toxicology profile of the trial agent(s);

Primary outcomes:
measure: Seizure-freedom rate
timeFrame: 6-month, 1-year and 2-year after surgery
Secondary outcomes:
measure: Seizure frequency reduction
timeFrame: 6-month, 1-year and 2-year after surgery
measure: ILAE classification of outcome
timeFrame: 6-month, 1-year and 2-year after surgery
measure: Seizure severity
timeFrame: 6-month, 1-year and 2-year after surgery
measure: Rate of mild complications
timeFrame: Within 1 month after surgery
measure: Cognitive function evaluation
timeFrame: 6-month, 1-year and 2-year after surgery
measure: Memory function evaluation
timeFrame: 6-month, 1-year and 2-year after surgery
measure: The quality of life
timeFrame: 6-month, 1-year and 2-year after surgery
measure: Length of hospital stay
timeFrame: Within 1 month after surgery
measure: Rate of reoperations
timeFrame: 6-month, 1-year and 2-year after surgery
measure: Rate of antiepileptic drug reduction or withdrawn
timeFrame: 6-month, 1-year and 2-year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Kai Zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mo J, Guo Z, Wang X, Zhang J, Hu W, Shao X, Sang L, Zheng Z, Zhang C, Zhang K. Magnetic resonance-guided laser interstitial thermal therapy vs. open surgery for drug-resistant mesial temporal lobe epilepsy: a propensity score matched retrospective cohort study. Int J Surg. 2024 Jan 1;110(1):306-314. doi: 10.1097/JS9.0000000000000811.