NIPH Clinical Trials Search

ARTCEREB Refill test Intrathecal of Study Effectiveness

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	cerebrospinal fluid hypovolemia
Date of first enrollment	16/01/2026
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	[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) (hereafter referred to as "BBS assessment") [Self-evaluation Prior to the CSF Refill Test] Within the one-week period prior to the CSF refill test, patients are required to perform a Visual Analog Scale (VAS) assessment on three separate days of their choice (twice per day, 3 days in total) as a self-evaluation at home. For each assessment day, the first VAS rating shall be performed in the standing position. After remaining in the supine position for 30 minutes, the second VAS rating shall be performed in the standing position within 5 minutes after standing up. [Assessment on the Day of the CSF Refill Test] On the day of the CSF refill test, both the Visual Analog Scale (VAS) assessment and the Berg Balance Scale (BBS) assessment will be performed immediately before the CSF refill test and within 5 minutes after needle removal following the procedure. Subsequently, a lumbar puncture will be performed using a standard technique. After confirming that the CSF opening pressure is below 200 mmH2O, 20 mL of Artocereb spinal irrigation solution will be intrathecally administered. A mid-injection pressure measurement will then be obtained, and if the CSF pressure remains below 200 mmH2O, the full volume will be administered. An end pressure will be measured after the completion of the full injection. If the mid-injection pressure reaches or exceeds 200 mmH2O, the injection will be discontinued at that point and the procedure will be terminated. Regardless of whether the injection is completed or interrupted, both the VAS and BBS assessments will be conducted again within 5 minutes after needle removal. The patient will then remain in the supine position for 1 hour for post-procedure rest, after which adverse events will be assessed. At 1 week (plus or minus 2 days) following the procedure, either an in-person clinical evaluation or a telephone interview will be conducted to assess adverse events, and the study participation will be concluded.

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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).