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

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.