Feasibility Clinical trial of endovascular EEG Measurement Device

JRCT ID: jRCTs032220543

Registered date:26/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: intractable epilepsy
• Date of first enrollment: 26/12/2022
• Target sample size: 5
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

eEEG 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Matsumaru Yuji
• Secondary Sponsor: E.P.Medical Inc.