Ultradźwięki kierowane rezonansem magnetycznym w leczeniu epilepsji opornej na leki: Wstępne wyniki badania klinicznego
MRgFUS for drug-resistant epilepsy: Preliminary report for prospective clinical trial
W skrócie
Badanie oceniało bezpieczeństwo i skuteczność nowej metody leczenia epilepsji opornej na leki, polegającej na ultradzwiękach kierowanych obrazowaniem rezonansem magnetycznym. U czterech pacjentów zastosowano tę metodę, celując w różne obszary mózgu, i zaobserwowano zmniejszenie liczby napadów u większości pacjentów bez poważnych powikłań. Mimo obiecujących wstępnych wyników, konieczne są dalsze badania na większej grupie pacjentów, aby potwierdzić skuteczność tej terapii i dopracować jej parametry.
Oryginalny abstract (angielski)
OBJECTIVE: To assess the safety, feasibility, and preliminary clinical outcomes of magnetic resonance-guided focused ultrasound (MRgFUS) for drug-resistant epilepsy (DRE). METHODS: This TFDA-regulated, open-label study enrolled four adults with DRE. MRgFUS targeted the anterior nucleus of the thalamus (ANT), the centromedian nucleus (CM), the posterior corpus callosum (CC), or the hypothalamic hamartoma (HH). The primary endpoints were safety and feasibility, while secondary endpoints included seizure frequency, EEG results, and postoperative MRI findings. RESULTS: The mean age of the patients was 34.7 years and the mean SDR was 0.38. Two of the procedures were performed under local anesthesia and three under general anesthesia. No serious adverse events, permanent neurological deficit, or postoperative cognitive decline were observed. At follow-up ranging from 3 to 15 months, seizure outcomes varied. The CM-treated patient showed stable overall seizure frequency with a 42.6% reduction in focal seizures. Posterior CC lesioning reduced interhemispheric EEG synchrony and was associated with a 15.9% reduction in generalized seizures. The HH case displayed a decrease in epileptiform activity on EEG and a 55.5% reduction of gelastic seizures, despite the absence of a definitive lesion. In the ANT case, the initial procedure was discontinued prior to reaching therapeutic temperatures, and the repeat treatment under general anesthesia was associated with a 66.0% seizure reduction at final follow-up. CONCLUSIONS: MRgFUS achieved lesion formation at selected epilepsy-related targets, including the first reported applications to the posterior CC and CM for epilepsy. However, the ability to achieve therapeutic temperatures and produce a definitive lesion varied among patients and was influenced by skull characteristics of the anatomical target. Given the small, heterogeneous cohort and limited follow-up, the observed clinical outcomes should be considered preliminary. Larger studies with longer follow-up are needed to establish efficacy and optimize treatment parameters.