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ARTCEREB Refill test Intrathecal of Study Effectiveness

Evaluation of the Effectiveness of the ARTCEREB Refill Test for Patients with Cerebrospinal Fluid Hypovolemia - ARISE study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061250079
Enrollment
80
Registered
2026-01-16
Start date
2026-01-16
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

[Evaluation Tools] The following assessment tools will be used: Pain assessment: Visual Analogue Scale (VAS) (hereafter referred to as "VAS assessment") Balance assessment: Berg Balance Scale (BBS) (
Lumbar puncture

Sponsors

Eiichi Nakai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants who meet at least one of the following conditions will be included: 1. Patients with apparent orthostatic headache and/or neck pain that improves within 5 minutes after assuming the supine position. 2. Patients who have persistent orthostatic symptoms such as lightheadedness or dizziness.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following conditions will be excluded: 1. Patients with a bleeding tendency. 2. Patients in whom lumbar puncture is difficult or contraindicated. 3. Pregnant women. 4. Patients deemed ineligible by the investigator. 5. Patients younger than 18 years of age at the time of consent (regardless of sex).

Design outcomes

Primary

MeasureTime frame
We will compare changes in orthostatic subjective symptom scores before and after intrathecal administration of ARTCELEB cerebrospinal surgery irrigation solution. In addition, we will examine the association between these symptom score changes and cerebrospinal fluid pressure.

Secondary

MeasureTime frame
The safety of the CSF refill test will be evaluated by assessing adverse events before and after administration of ARTCELEB cerebrospinal surgery irrigation solution.

Contacts

Public ContactNakai Eiichi

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