Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy

Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Patients With Drug-resistant Epilepsy

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Device: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT); Novel, minimally invasive MRgLITT.	Device: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT); MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.
No Intervention: Open Surgery (OS); Traditional OS, including ATL, SAH and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure-freedom rate	Percentage	6-month, 1-year and 2-year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency reduction	Times/Months	6-month, 1-year and 2-year after surgery
ILAE classification of outcome	International League Against Epilepsy (ILAE) Outcome Scale. The scale ranges from 1 to 6. The higher value indicates more frequency seizures.	6-month, 1-year and 2-year after surgery
Seizure severity	National Hospital Seizure Severity Scale (NHS3). The scale generates a score from 1 to 27. Higher score indicates more severer seizures.	6-month, 1-year and 2-year after surgery
Rate of mild complications	Percentage	Within 1 month after surgery
Cognitive function evaluation	Multiple Ability Self-Report Questionnaire (MASQ). The questionnaire ranges from 38 to 190. Higher score indicates more severer cognitive dysfunction.	6-month, 1-year and 2-year after surgery
Memory function evaluation	Memory Functioning Scale Self-Report (MFS-S). The questionnaire ranges from 0 to 42. Higher score indicates more severer memory dysfunction.	6-month, 1-year and 2-year after surgery
The quality of life	The EuroQol 5 Dimension 5 Level (ED-5Q-5L). The questionnaire ranges from 0 to 100. Higher score indicates better quality of life.	6-month, 1-year and 2-year after surgery
Length of hospital stay	Days	Within 1 month after surgery
Rate of reoperations	Percentage	6-month, 1-year and 2-year after surgery
Rate of antiepileptic drug reduction or withdrawn	Percentage	6-month, 1-year and 2-year after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Kai Zhang, Dr., Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): March 14, 2026

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Seizure Control; MRgLITT; Drug-resistant Epilepsy; Functional Preservation; Real-world STUDY
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: KY2024-053-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact jiajiemo@foxmail.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No