Authors :
Mary McNeil, MS – NeuroOne
Guadalupe Zepeda, BS – NeuroOne
Maria Porto Cruz, Ph.D. – NeuroOne
Maria Vomero, Ph.D. – NeuroOne
Alfonso Chavez, BS – NeuroOne
Nidhi Kalia, BS – NeuroOne
Hijaz Haris, BS – NeuroOne
Debra Kridner, BS – NeuroOne
Mark Christianson, BS – NeuroOne
Dave Rosa, MS – NeuroOne
Camilo Diaz-Botia, Ph.D. – NeuroOne
Presenting Author: Aura Kullmann, PhD – NeuroOne
Rationale:
Introduction: sEEG-guided radiofrequency ablation (RFA) is an emerging therapeutic option for drug-resistant epilepsy patients. The procedure leverages the implanted sEEG electrodes for seizure localization to deliver targeted thermal ablations. In 2023, the FDA cleared the first sEEG-guided RFA system with real-time temperature monitoring and control.
Here we describe the development of this RFA system from bench to bedside.
Methods:
Lesions were assessed in size in ex vivo chicken breast and in vivo swine brain (70–90°C; 30–600s). Clinical experience was summarized from published literature1, surgeon feedback, and a patient interview.
Results:
The system was designed to incorporate placement of a thermocouple behind the ablation contact(s) to continuously monitor temperature and impedance. The generator dynamically adjusts power to maintain target temperature. Users can modify ablation parameters (temperature, duration) in real-time. Lesion size in chicken breast and swine brain were proportional to temperature and duration and were similar in size. For 80-85°C and 2-5min duration lesions diameter was 6-8mm.
Initial clinical experience was presented at the American Epilepsy Society 2024 meeting. In one center (Cleveland Clinic), three patients underwent sEEG-guided RFA (80–85°C, 2–5min, bipolar configuration). The procedure was well tolerated and lesions averaging 7–8 mm in diameter were visible in the MRI. Another patient who underwent RFA at the Mayo Clinic Jacksonville was interviewed ~7 months post-RFA and reported full recovery and seizure freedom. Surgeons found the system safe, reliable, and easy to use, both in preclinical and clinical settings. Real-time thermal feedback allowed for controlled and consistent lesioning.
Conclusions:
The temperature-controlled sEEG-guided RFA system produced consistent lesions across ex vivo, in vivo, and human applications. This system offers a promising tool for focal epilepsy diagnosis and treatment, with the potential to keep patients on the path to seizure freedom with a minimally-invasive step, bedside, without care interruption.
Reference: AES 2024 abstract and poster1.552
Funding: NeuroOne