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NCT Number: NCT06720922

MRgLITT for mTLE: A PROBE Trial

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

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Key information

Conditions

Temporal Lobe Epilepsy (TLE) Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epilepsy, Temporal Lobe Epileptic Syndromes Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Jiajie Mo, Dr.

CONTACT

[email protected]

86 01059975051

About this study

  • 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).
  • Explore the factors associated with seizure outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT)

Procedure

MRgLITT employs laser energy delivered through a stereotactically placed laser applicator to precisely ablate the epileptogenic tissue.

Open Surgery

Procedure

Traditional Open Surgery

Primary outcomes

  1. Seizure freedom rate

    Time frame: 6-month, 1-year after surgery

    According to International League Against Epilepsy [ILAE] Outcome Scale

Secondary outcomes

  1. Seizure frequency

    Time frame: 6-month, 1-year after surgery

    Times/Months

  2. Seizure severity

    Time frame: 6-month, 1-year after surgery

    National Hospital Seizure Severity Scale (NHS3)

  3. Cognitive function evaluation

    Time frame: 6-month, 1-year after surgery

    Multiple Ability Self-Report Questionnaire (MASQ)

  4. Memory function evaluation

    Time frame: 6-month, 1-year after surgery

    Multifactorial Memory Questionnaire (MMQ)

  5. Quality of life for epilepsy patients

    Time frame: 6-month, 1-year after surgery

    EQ-5D-5L

  6. Adverse events

    Time frame: within 7 days, 6-month, 1-year after surgery

    percentage

  7. Severe adverse events

    Time frame: within 7 days, 6-month, 1-year after surgery

    percentage

  8. Length of hospital stay

    Time frame: after surgery

    days

  9. Rate of antiepileptic drug reduction or withdrawn

    Time frame: 1-year after surgery

    percentage

  10. Rate of reoperations

    Time frame: 1-year after surgery

    percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Zhang, Dr.

CONTACT

[email protected]

86 01059975051

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: MINE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 6, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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