Evaluation of Overflow leak test
Phase 2
Recruiting
- Conditions
- intracranial hypotension
- Registration Number
- JPRN-jRCTs061190002
- Lead Sponsor
- akai Eiichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
1. Patient with intracranial hypotension(Patient confirmed to have cerebrospinal fluid pressure below 60mmH2O)
2. Patient 18 years old or above
3. Written consent concerning participation in this research has been obtained from the participant (or from the individual legal guardian if incapable of consenting)
Exclusion Criteria
1. Patient with a bleeding tendency
2. Patient for whom a lumbar puncture would be difficult
3. Pregnant woman
4. Patient deemed unfit by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the effectiveness of identifying leakage sites with the overflow leak test through comparison of the overflow leak test and CT myelogram
- Secondary Outcome Measures
Name Time Method (1) Comparison of MRI image findings taken as routine care before Overflow leak test and MRI image findings at Overflow leak test.<br>(2) Name of adverse event, date of onset, severity (severity), severity, treatment for study subject, outcome and date of outcome, causal relationship with the concerned study.