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

Drug Resistant Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06341075
• Other study ID #: KY2024-053-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: March 14, 2026

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: March 14, 2026
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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);

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure-freedom rate	Percentage	6-month, 1-year and 2-year after surgery
Secondary	Seizure frequency reduction	Times/Months	6-month, 1-year and 2-year after surgery
Secondary	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
Secondary	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
Secondary	Rate of mild complications	Percentage	Within 1 month after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay	Days	Within 1 month after surgery
Secondary	Rate of reoperations	Percentage	6-month, 1-year and 2-year after surgery
Secondary	Rate of antiepileptic drug reduction or withdrawn	Percentage	6-month, 1-year and 2-year after surgery