Authors :
Presenting Author: Yosuke Masuda, MD PhD – University of Tsukuba
Kota Araki, MD – University of Tsukuba
Hosoo Hisayuki, MD PhD – University of Tsukuba
Mitsuyo Nishimura, ET – University of Tsukuba Hospital
Hiroki Ishida, M.E. – Epsilon Medical Inc
Eiichi Ishikawa, MD, PhD, – University of Tsukuba
Yuji Matsumaru, MD PhD – University of Tsukuba
Rationale:
The gold standard for localizing epileptic foci is the intracranial electrode. We developed a novel endovascular EEG device, EP-01, which enables minimally invasive placement of multiple electrodes via the venous system. A pivotalclinical trial is ongoing in Japan to assess the feasibility of long-term seizure monitoring using EP-01. We hypothesized that EP-01, similar to SEEG and other intracranial electrodes, can determine lateralization of the epileptic focus. Here, we present the first three cases of ictal EEG recording using EP-01.
Methods:
This multicenter, prospective trial includes patients aged 15–69 years with drug-resistant epilepsy who are scheduled for intracranial electrode implantation and have venous anatomy suitable for symmetrical placement of EP-01. Exclusion criteria include generalized epilepsy, thrombophilia, coagulation disorders, metal allergy, and pregnancy. Enrollment was planned for 37 patients. EP-01 electrodes were bilaterally placed in the cavernous sinuses, transverse sinuses, and superior sagittal sinus via the jugular veins for EEG recording. The primary endpoint was concordance in seizure lateralization between EP-01 and conventional intracranial EEG. Safety was also evaluated. Nine patients have been enrolled at our institution; this report includes three cases with completed central adjudication.
Results:
Case 1: A 25-year-old woman showed right hemispheric seizures on scalp EEG without MRI lesion. Intracranial EEG confirmed ictal activity in the right mesial temporal lobe. EP-01 placed in the right transverse sinus recorded corresponding ictal EEG.
Case 2: A 35-year-old man had a cavernous hemangioma in the right lateral temporal lobe. Seizure onset was confirmed in this region with intracranial EEG. EP-01 in the right cavernous sinus also captured ictal activity.
Case 3: A 31-year-old man had agenesis of the anterior corpus callosum and bilateral hippocampal atrophy. Scalp EEG suggested right temporal onset. However, 55 hours after implantation, EP-01 in the cavernous sinus had dislodged, and no ictal data were recorded.
In all cases, six intravascular electrodes were placed successfully. No thrombotic, puncture-related, or other adverse events were observed. Recording durations ranged from 55 to 124 hours.
Conclusions:
Long-term ictal recording with EP-01 was feasible. In cases where the device remained in place, seizure activity could be detected near the focus, including from the jugular vein. Further evaluation in a larger cohort is needed to confirm these findings.
Funding: This study was supported by funding from Epsilon Medical Institute.