MRgLITT for mTLE: A PROBE Trial (MINE)

Capital Medical University

Status: Enrolling

Conditions: Temporal Lobe Epilepsy (TLE)

Treatments: Procedure: Open Surgery; Procedure: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06720922

KY2025-073-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Open Surgery (anterior temporal lobectomy, ATL)

Experimental group

Treatment:

Procedure: Open Surgery

Minimally Invasive Surgery (MRgLITT)

Active Comparator group

Treatment:

Procedure: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)