Safety assessment of 20 mL intrathecal injection in CSF refill test

JRCT ID: jRCTs061210050

Registered date:18/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebrospinal fluid hypovolemia
• Date of first enrollment: 18/11/2021
• Target sample size: 15
• Study type: Interventional
• Intervention(s): In the CSF refill test, we evaluate the pain by standing and measure the time of walking 10m before the CSF refill test. Then, lumbar puncture is performed by a general lumbar puncture method to confirm that the cerebrospinal fluid pressure is 100 mmH2O or less, and then 20 mL of ARTCEREB is intramedullarily injected. The final pressure is alsomeasured after full injection. If the intermediate pressure is 200 mmH2O or more, the injection is stopped at that point and the injection is terminated.Regardless of whether the injection is interruptedor completed, the walking time of 10 m is measured after the injection is completed, and the pain in the standing position is evaluated(VAS) . After that, rest in a lying position for 1 hour, and then confirm adverse events. About one week before and after that, a medical examination or contact will be made to confirm adverse events. And the study will be completed.

Outcome(s)

• Primary Outcome: We examine the safety of the CSF refill test by assessing adverse events before and after injecting 20 mL of ARTCEREB.

Secondary Outcome

1. We measure the initial, intermediate and final pressures of cerebrospinal fluid during lumbar puncture.
2. We evaluate the VAS score before and after ARTCEREB intrathecal injection.
3. We measure the time to walk 10 m before and after intrathecal injection.

Key inclusion & exclusion criteria

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

Include criteria

Patients who meet all of the following criteria are targeted.
1. Patients with overt orthostatic headache and suspected cerebrospinal fluid hypovolemia
2. Patients with CSF pressure of 100mmH2O or less
3. Patients over 18 years old
4. Patients who have given written consent to participate in this study(If you are a minor or you do not have the ability to consent, you will be a substitute)

Exclude criteria

Patients who fall under any of the following are excluded.
1. Patients who tend to bleed
2. Patients who have difficulty with lumbar puncture
3. Pregnant woman
4. Patients recognized by doctors ineligible

Related Information

• Primary Sponsor: Nakai Eiichi