NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061190023

Registered date:14/11/2019

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

Basic Information

Recruitment status Suspended
Health condition(s) or Problem(s) studiedcerebrospinal fluid hypovolemia
Date of first enrollment14/11/2019
Target sample size10
Countries of recruitment
Study typeInterventional
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. After that, we perform lumbar puncture using the usual lumbar puncture method and inject 10 ml of ARTCEREB. We also measure cerebrospinal fluid pressure before and after injection. We evaluate symptom changes in a standing position immediately after injection. Pain is evaluated using the VAS score. The patient will then remain at rest for one hour, after which we will confirm the adverse event. The next day we finish by checking the condition on the phone.

Outcome(s)

Primary OutcomeThis 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 Outcome(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.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1.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)
Exclude criteria1. 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

Contact

Public contact
Name Eiichi Nakai
Address Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi Japan 783-8505
Telephone +81-88-880-2397
E-mail enakai@kochi-u.ac.jp
Affiliation Kochi Medical School Hospital
Scientific contact
Name Eiichi Nakai
Address Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi Japan 783-8505
Telephone +81-88-880-2397
E-mail enakai@kochi-u.ac.jp
Affiliation Kochi Medical School Hospital