MRgLITT for mTLE: A PROBE Trial

Not Applicable

Recruiting

• Conditions: Temporal Lobe Epilepsy (TLE)

• Registration Number: NCT06720922
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in mesial temporal lobe epilepsy (mTLE)?

Detailed Description

1. Compare the clinical prognosis between magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) and traditional open surgery (OS) on patients with mesial temporal lobe epilepsy (mTLE).

2. Explore the factors associated with seizure outcomes.

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Status Verified: 2025-07
• Study Start: 2025-07-21
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18-65 years.
• Drug-resistant mesial temporal lobe epilepsy.
• Seizure frequency ≥ 1 time /month.
• Participants approved.

Exclusion Criteria

• History of brain surgery.
• Intracranial space occupying lesions.
• Individuals with significant medical comorbidities or conditions that pose an excessive risk for surgery, such as severe cardiovascular disease, respiratory disorders, or uncontrolled systemic infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seizure freedom rate	6-month, 1-year after surgery	According to International League Against Epilepsy \[ILAE\] Outcome Scale

Secondary Outcome Measures

Name	Time	Method
Seizure frequency	6-month, 1-year after surgery	Times/Months
Seizure severity	6-month, 1-year after surgery	National Hospital Seizure Severity Scale (NHS3)
Cognitive function evaluation	6-month, 1-year after surgery	Multiple Ability Self-Report Questionnaire (MASQ)
Memory function evaluation	6-month, 1-year after surgery	Multifactorial Memory Questionnaire (MMQ)
Quality of life for epilepsy patients	6-month, 1-year after surgery	EQ-5D-5L
Adverse events	within 7 days, 6-month, 1-year after surgery	percentage
Severe adverse events	within 7 days, 6-month, 1-year after surgery	percentage
Length of hospital stay	after surgery	days
Rate of antiepileptic drug reduction or withdrawn	1-year after surgery	percentage
Rate of reoperations	1-year after surgery	percentage

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China