MRgLITT for mTLE: A PROBE Trial (MINE)

January 19, 2026 updated by: Kai Zhang, Beijing Tiantan Hospital

Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Mesial Temporal Lobe Epilepsy: A Prospective, Randomized, Open Blinded, End-point Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Surgery (anterior temporal lobectomy, ATL)
Procedure: Open Surgery
Traditional Open Surgery
Active Comparator: Minimally Invasive Surgery (MRgLITT)
Procedure: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)
MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure freedom rate
Time Frame: 6-month, 1-year after surgery
According to International League Against Epilepsy [ILAE] Outcome Scale
6-month, 1-year after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025-073-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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