The study "Safety and Efficacy Evaluation of MR-Guided Focused Ultrasound Anterior Thalamic Nucleus Ablation for Drug-Resistant Epilepsy" from Chinese PLA General Hospital, is a single-center, prospective, single-arm study. It uses a MR-guided Focused Ultrasound Therapy System and plans to recruit 20 patients with drug-resistant epilepsy who are ≥20 years old, have a WAIS score ≥70, an average of ≥3 monthly epileptic seizures in the 3 months before enrollment, and are refractory to at least 2 antiepileptic drugs (including 1 first-line drug), excluding those with unstable cardiac function, brain tumors, previous brain surgery history, etc. Anterior thalamic nucleus ablation is performed via MRgFUS, with multiple follow-ups from 48 hours to 2 years postoperatively. Safety is evaluated by the incidence of adverse events within 2 years, efficacy by seizure frequency recorded in epilepsy diaries and the QOLIE-31 scale. Statistical analysis is conducted using toolkits, while risks such as MRI-induced claustrophobia and CT radiation are controlled. It adheres to GCP and the Declaration of Helsinki to ensure data authenticity and subjects' rights. The technology provider is responsible for the normal operation of the device and providing 20 sets of treatment consumables.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
MR-guided Focused Ultrasound Therapy focusing Anterior Nucleus of the thalamus
Safety
Evaluate the incidence of adverse events (AEs) within 2 years after treatment with the investigational medical device.
Time frame: From enrollment to the end of treatment at 1 year
Efficacy
The efficacy evaluation indicator is the frequency of epileptic seizures, and the data are collected through the epilepsy seizure diary. Quality of life will be measured using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31).
Time frame: From enrollment to the end of treatment at 1 year
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