NIPH Clinical Trials Search

JRCT ID: jRCTs032220543

Registered date:26/12/2022

Feasibility Clinical trial of endovascular EEG Measurement Device

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedintractable epilepsy
Date of first enrollment07/02/2023
Target sample size5
Countries of recruitment
Study typeInterventional
Intervention(s)As the WADA test is performed, the test device is temporarily implanted in the cerebral vein from the jugular vein. The eEEG measurements will be performed at the time of the test device implantation and compared to EEG with scalp electrodes. Intraoperative and postoperative assessments will be performed.


Primary OutcomeeEEG acquisition performance / Confirmation of similarity with EEG acquired from scalp electrode
Secondary Outcome/ Induction of electroencephalogram (eEEG) changes by propofol / Whether or not the opening and closing of the eyes induce eEEG changes. / Comparison of signal sensitivity (voltage) with scalp electrode EEG / Confirmation of lateralization match (when a focus can be diagnosed by the test equipment during the WADA test, comparison with the results of focal identification by subdural electrodes to be performed later ). / Confirmation of tip electrode position during WADA test. / Success rate of the procedure (i.e., was the device able to reach the target vessel while the microcatheter was in the intended area?) /Safety endpoints / Rate of bleeding and thrombosis / Rate of intracorporeal remnants / Total adverse events / Total device failures *Adverse events will be collected from the time when the study device is inserted until the telephone interview one week later.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 70age old
Include criteria1) Intractable epilepsy patients 2) Patients for whom the WADA test is performed 3) Patients with the vascular anatomy that allows catheter placement into either the cavernous sinus, transverse sinus, or superior sagittal sinus 4) Patients between the ages of 18 and 70 (at the time of obtaining consent)
Exclude criteria1) Patients with intellectual disability of moderate level or higher (*1) 2) Patients with occlusion or thrombus in the common carotid artery or internal jugular vein 3) Patients who are receiving antithrombotic therapy 4) Patients with a predisposition to bleeding or coagulation abnormalities (*2) 5) Patients allergic to contrast media 6) Patients with metal allergies 7) Patients who are pregnant or of childbearing potential 8) Patients who are judged by the investigator to be inappropriate to participate in this study. *1: The criteria for intellectual disability are as follows Mild: able to work Moderate: Able to answer questions but unable to work Severe: Unable to speak *2: Criteria for predisposition to bleeding and coagulation abnormalities are as follows Platelet count: less than 100,000/micro L APTT: 39 seconds or longer PT-INR: 1.1 or higher

Related Information


Public contact
Name Yuji Matsumaru
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3199
Affiliation University of Tsukuba Hospital
Scientific contact
Name Yuji Matsumaru
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3199
Affiliation University of Tsukuba Hospital