Authors :
Presenting Author: Kota Araki, MD – University of Tsukuba
Yosuke Masuda, MD PhD – University of Tsukuba
Mitsuyo Nishimura, ET – University of Tsukuba Hospital
Hosoo Hisayuki, MD PhD – University of Tsukuba
Hiroki Ishida, M.E. – Epsilon Medical Inc
Ayataka Fujimoto, MD PhD – Dokkyo Medical Univeristy
Takashi Enokizono, MD PhD – University of Tsukuba
Kensuke Kawai, MD PhD – Jichi Medical University
Yuji Matsumaru, MD PhD – University of Tsukuba
Eiichi Ishikawa, MD PhD – University of Tsukuba
Rationale:
EP-01 is a newly designed endovascular electrode intended for minimally invasive intracranial EEG acquisition. This study aimed to assess the feasibility of signal acquisition, short-term safety, and technical performance of EP-01, using scalp EEG as a reference to evaluate its recording capability.Methods:
A single-center, prospective feasibility study was conducted in five patients with drug-resistant focal epilepsy undergoing Wada testing. Up to six EP-01 electrodes, each featuring a platinum monopolar tip, were navigated into major cerebral venous sinuses using a microcatheter. Simultaneous recordings from EP-01 (endovascular EEG, or eEEG) and scalp EEG were obtained. The primary endpoint was successful acquisition of eEEG signals. Secondary assessments included spike detection sensitivity compared with scalp EEG, technical feasibility of deployment, and short-duration safety of EP-01.Results:
All five patients underwent successful implantation of EP-01 electrodes (average 4.5 per case), and simultaneous recordings with scalp EEG were completed. In two of the five cases, a total of 158 interictal spikes were detected by EP-01. The median amplitude of spikes recorded by eEEG was 130.4 μV, with 57.0% of these undetectable by scalp EEG (p < 0.001). Electrode displacement due to neck movement was minimal (median 3.45 mm). No adverse events—including hemorrhagic or thrombotic complications—occurred during or shortly after the approximately 70-minute monitoring period. All electrodes were safely retrieved.