Feasibility Clinical trial of endovascular EEG Measurement Device
- Conditions
- intractable epilepsy
- Registration Number
- JPRN-jRCTs032220543
- Lead Sponsor
- Matsumaru Yuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method