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Recruiting NCT06720922

MRgLITT for mTLE: A PROBE Trial

No phase Interventional Temporal Lobe Epilepsy (TLE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT), Open Surgery.
Who it may be relevant to
Registry conditions: Temporal Lobe Epilepsy (TLE). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • Procedure Open Surgery
    Traditional Open Surgery

Primary outcome measures

  • Seizure freedom rate [Time frame: 6-month, 1-year after surgery]
Secondary outcome measures (10)
  • Seizure frequency [Time frame: 6-month, 1-year after surgery]
  • Seizure severity [Time frame: 6-month, 1-year after surgery]
  • Cognitive function evaluation [Time frame: 6-month, 1-year after surgery]
  • Memory function evaluation [Time frame: 6-month, 1-year after surgery]
  • Quality of life for epilepsy patients [Time frame: 6-month, 1-year after surgery]
  • Adverse events [Time frame: within 7 days, 6-month, 1-year after surgery]
  • Severe adverse events [Time frame: within 7 days, 6-month, 1-year after surgery]
  • Length of hospital stay [Time frame: after surgery]
  • Rate of antiepileptic drug reduction or withdrawn [Time frame: 1-year after surgery]
  • Rate of reoperations [Time frame: 1-year after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

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. PMID 37800596
  • Mo J, Cai D, Zhou Q, Dong S, Li Q, Zhao B, Wang X, Zhang C, Hu W, Zheng Z, Sang L, Shao X, Zhang J, Zhu L, Wang Z, Wu Y, Wang A, Zhang K. Magnetic resonance-guided laser interstitial thermal therapy for mesial temporal lobe epilepsy (MINE): a single-centre, prospective, randomised, open-label, blinded-endpoint controlled trial protocol in China. BMJ Open. 2026 Jul 9;16(7):e117930. doi: 10.1136/bmj PMID 42425569

Identifiers

NCT: NCT06720922 · KY2025-073-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗