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Safety assessment of 20 mL intrathecal injection in CSF refill test

Safety Assessment of on the usefulness of intraspinal injection of cleaning perfusate for cerebrospinal surgery ARTCEREB in cerebrospinal fluid hypovolemia. - SUIC study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061210050
Enrollment
15
Registered
2021-11-18
Start date
2022-04-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebrospinal fluid hypovolemia cerebrospinal fluid hypovolemia

Interventions

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 confi
Lumbar puncture

Sponsors

Nakai Eiichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
We examine the safety of the CSF refill test by assessing adverse events before and after injecting 20 mL of ARTCEREB.

Secondary

MeasureTime frame
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.

Contacts

Public ContactEiichi Nakai

Kochi Medical School Hospital

enakai@kochi-u.ac.jp+81-88-880-2397

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026