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EndoVascular EEG device to confirm abnormal cerebral activity on poor grade SubArachnoid Hemorrhage

EndoVascular EEG device to confirm abnormal cerebral activity on poor grade SubArachnoid Hemorrhage - EVE SAH-Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250055
Enrollment
20
Registered
2025-04-22
Start date
2025-08-12
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe grade subarachnoid hemorrhage

Interventions

1) The placement of the endovascular EEG electrode is performed under X-ray fluoroscopy. Sheaths are placed in both jugular veins, and a microcatheter is advanced into the target cerebral venous vesse

Sponsors

Ito Yoshiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with subarachnoid hemorrhage (SAH) classified as WFNS grade IV or V. 2) Patients without bilateral pupil dilation. 3) Patients for whom examination and treatment of ruptured cerebral aneurysm are feasible. 4) Patients with vascular anatomy that allows catheter navigation into the cavernous sinus, transverse sinus, superior sagittal sinus. 5) Patients aged 18 years or older at the time of consent. 6) Patients who have received a full explanation of the study, fully understood it, and provided written informed consent voluntarily, either personally or through a legally authorized representative.

Exclusion criteria

Exclusion criteria: 1) Patients with jugular vein occlusion or thrombosis. 2) Patients with bleeding tendencies or coagulation disorders. 3) Patients with severe contrast agent allergy. 4) Patients with metal allergy. 5) Patients who are pregnant. 6) Patients deemed inappropriate for participation in this study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Occurrence and location of EEG alerts based on alpha/delta ratio (ADR) in scalp and endovascular EEG electrodes. (EEG alert is defined as a decrease of 10% or more from baseline lasting for 6 hours or longer, or a decrease of 50% or more lasting for 1 hour or longer).

Secondary

MeasureTime frame
1) Occurrence and location of EEG alerts based on Relative Alpha Variability (RAV) in scalp and intravascular EEG electrodes (defined as a worsening of the RAV score by 1 or more compared to the previous 8-12 hours). 2) Occurrence and location of EEG alerts based on Alpha-Theta/Delta Ratio (AT/D) in scalp and intravascular EEG electrodes (defined as a decrease of 30% or more from baseline lasting for 4 hours or longer). 3) Occurrence and location of epileptiform discharges in scalp and endovascular EEG electrodes. 4) Delayed cerebral ischemia, new focal neurological deficits, or a Glasgow Coma Scale (GCS) decline of 2 or more points lasting for at least 1 hour (excluding rebleeding, hydrocephalus, increased intracranial pressure [IICP], treatment-related complications, seizures, or systemic complications), or cerebral infarction detected on CT/MRI. 5) Cerebral vasospasm (defined as 34% or more narrowing of the vascular lumen on CT, MRI, or DSA). 6) Measurement duration. 7) Functional outcome at discharge (assessed using the modified Rankin Scale). 8) Adverse events.

Contacts

Public ContactYoshiro Ito

University of Tsukuba Hospital

yoshiro@md.tsukuba.ac.jp+81-29-853-3220

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026