Exploratory study on the usefulness of CSF refill test in cerebrospinal fluid hypovolemia

Exploratory study on the usefulness of intraspinal injection of cleaning perfusate for cerebrospinal surgery in cerebrospinal fluid hypovolemia - EUIC study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061190023

Enrollment

Registered

2019-11-14

Start date

2019-11-14

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. After that, we perform lumbar puncture using the usual lumbar puncture method a

lumbar puncture

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients suspected of having cerebrospinal fluid deficiency with clear orthostatic symptoms (such as orthostatic headache) that disappear in the supine position 2. Patients with CSF pressure of 100mmH2O or less 3. Patients over 18 years old 4. Persons who have obtained written consent from the person concerned (in the case of minors and persons who lack consent ability)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
This study examines the usefulness of CSF refill test for the diagnosis of cerebrospinal fluid reduction by comparing headache assessment (VAS) before and after ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery injection as CSF refill test.	—

Secondary

Measure	Time frame
(1) In the CSF refill test, we measure the initial pressure at the time of lumbar puncture and the final pressure after injecting 10 mL of ARTCEREB, and observe the change in cerebrospinal fluid pressure before and after the puncture. (2) In the CSF refill test, we measure the initial pressure at the time of lumbar puncture and the final pressure after injecting 10 mL of ARTCEREB, and examine the relationship between changes in cerebrospinal fluid pressure before and after puncture and headache evaluation (VAS). (3) We compare 10m walking time before and after CSF refill test. (4) We evaluate adverse event name, date of onset, severity (severity), severity, treatment of study subjects, outcome and outcome date, and causal relationship with the study.	—

Measure

Time frame

(1) In the CSF refill test, we measure the initial pressure at the time of lumbar puncture and the final pressure after injecting 10 mL of ARTCEREB, and observe the change in cerebrospinal fluid pressure before and after the puncture. (2) In the CSF refill test, we measure the initial pressure at the time of lumbar puncture and the final pressure after injecting 10 mL of ARTCEREB, and examine the relationship between changes in cerebrospinal fluid pressure before and after puncture and headache evaluation (VAS). (3) We compare 10m walking time before and after CSF refill test. (4) We evaluate adverse event name, date of onset, severity (severity), severity, treatment of study subjects, outcome and outcome date, and causal relationship with the study.

—

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