{
  "abstract": "Introduction Drug-resistant mesial temporal lobe epilepsy (mTLE) is a common and disabling focal epilepsy syndrome for which surgery offers the best chance of seizure freedom. Traditional open surgery (eg, anterior temporal lobectomy or selective amygdalohippocampectomy) is effective but may be associated with perioperative morbidity and neurocognitive sequelae. Magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) is a minimally invasive alternative with encouraging observational outcomes but high-quality comparative evidence versus open surgery remains limited. The MINE trial is designed to compare MRgLITT with open surgery in patients with mTLE.Methods and analysis MINE is a prospective, randomised, open-label, blinded-endpoint trial. Eligible adults with drug-resistant TLE who complete a comprehensive presurgical evaluation and are deemed suitable for surgical treatment will be enrolled at participating centres. Participants will be randomised 1:1 (block randomisation) to receive MRgLITT or open surgery. Because of the nature of surgical interventions, participants and treating teams will not be blinded; however, outcome assessors and statistical analysts will remain blinded to treatment allocation. The primary outcome is seizure-free rate at 12 months after surgery, defined as International League Against Epilepsy (ILAE) Class 1. Secondary outcomes include: (1) broader seizure outcomes (ILAE class distribution, seizure frequency and seizure severity) assessed at 6 and 12 months; (2) cognitive and memory function assessed at 6 and 12 months; (3) postoperative safety outcomes collected from surgery through discharge and at follow-up visits at 6 and 12 months, and (4) healthcare utilisation and health-economic outcomes: length of hospital stay measured during hospitalisation; and reoperation, antiseizure medication reduction and quality of life assessed at 6 and 12 months. Safety outcomes include perioperative adverse events (AEs) and serious AEs (SAEs), collected from surgery through discharge and at follow-up visits at 6 and 12 months. This trial is powered as a non-inferiority study on the primary outcome, which based on prior data reporting 12-month seizure-free rates of 76.9% for MRgLITT and 76.0% for open surgery, the assumed absolute difference is 0.009. The non-inferiority margin was set at −0.23, informed by the minimum acceptable benefit threshold reported in patient preference research.Ethics and dissemination The study has received ethics approval from the Institutional Review Board of Beijing Tiantan Hospital (KY2025-073-01). Written informed consent will be obtained from all participants prior to enrolment. Results will be disseminated through peer-reviewed publications and academic presentations.Trial registration number NCT06720922.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Jiajie Mo"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Du Cai"
    },
    {
      "affiliations": [
        "Department of Epidemiology, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing, China"
      ],
      "name": "Quan Zhou"
    },
    {
      "affiliations": [
        "Institute for Hospital Management, Tsinghua University, Beijing, China"
      ],
      "name": "Sihan Dong"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Qian Li"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Baotian Zhao"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Xiu Wang"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Chao Zhang"
    },
    {
      "affiliations": [
        "Department of Functional Neurosurgery, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Wenhan Hu"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Fengtai Hospital, Beijing, China"
      ],
      "name": "Zhong Zheng"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Fengtai Hospital, Beijing, China"
      ],
      "name": "Lin Sang"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Beijing, China"
      ],
      "name": "Xiaoqiu Shao"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China",
        "Department of Functional Neurosurgery, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Jianguo Zhang"
    },
    {
      "affiliations": [
        "Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Lin Zhu"
    },
    {
      "affiliations": [
        "Department of Neurology and Neurosurgery, University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, Netherlands"
      ],
      "name": "Ziyi Wang"
    },
    {
      "affiliations": [
        "Institute for Hospital Management, Tsinghua University, Beijing, China",
        "School of Healthcare Management, Tsinghua Medicine, Tsinghua University, Beijing, China"
      ],
      "name": "You Wu"
    },
    {
      "affiliations": [
        "Department of Epidemiology, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing, China"
      ],
      "name": "Anxin Wang"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Tiantan Hospital, Beijing, China",
        "Department of Functional Neurosurgery, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Kai Zhang"
    }
  ],
  "title": "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",
  "uid": "8fe17661-3b46-5abc-9afd-af6e8fc56f9c"
}