Efficacy evaluation of Overflow leak test by 30 mL intrathecal injection

JRCT ID: jRCTs061220082

Registered date:12/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebrospinal fluid hypovolemia
• Date of first enrollment: 12/01/2023
• Target sample size: 25
• Study type: Interventional

Intervention(s)

Overflow leak test
Lumbar puncture is performed by the general lumbar puncture method, and 30 mL of ARTCEREB is intramedullarily injected. MRI will be taken within 1 hour after intrathecal injection. The site where the change is observed compared with the MRI image before intramedullary injection is judged to have a high possibility of leakage. After that, adverse events will be confirmed the next day and 5 days later, and the study will be terminated.

Outcome(s)

• Primary Outcome: Comparison of the rate at which the leak site could be identified by CT myelography images and the rate at which the leak site could be identified by the 30 mL intrathecal injection Overflow leak test

Secondary Outcome

(1) Comparison of the rate at which the leak site could be identified by CT myelography images and the rate at which the leak site could be identified by the Overflow leak test (including discontinued cases)
(2) Changes in MRI images before and after the Overflow leak test

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with low cerebrospinal fluid pressure (patients whose cerebrospinal fluid pressure of 60 mmH2O or less has been confirmed even once)
2. Patients over 18 years old
3. Persons who have obtained written consent from the person concerned (in the case of minors and persons who lack consent ability)

Exclude criteria

1. Patients who tend to bleed
2. Patients who have difficulty with lumbar puncture
3. Pregnant woman
4. Patients recognized by doctors as ineligible

Related Information

• Primary Sponsor: Nakai Eiichi