Idiopathic Normal Pressure Hydrocephalus: Comparing Different Shunt Surgery Options to Improve Treatment Outcomes

Registry-based Assessment of Shunt Operation Methods and Outcomes in Idiopathic Normal Pressure Hydrocephalus (RASHOMON study): A Protocol for a Multicenter Cohort Study - RASHOMON study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1040250005

Enrollment

288

Registered

2025-04-15

Start date

2024-12-19

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

Idiopathic Normal Pressure Hydrocephalus (iNPH) Normal pressure hydrocephalus, shunt, VP,LP,VA

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 60 and 85 years Presence of at least one symptom among gait disturbance, cognitive impairment, or urinary dysfunction Ventricular enlargement (Evans Index > 0.3) or narrowed callosal angle (< 90 degree) Findings on brain MRI or CT showing narrowing of the subarachnoid space at the high convexity or midline region (DESH like findings)

Exclusion criteria

Exclusion criteria: Inability to obtain informed consent Presence of an evident pre-existing condition causing hydrocephalus Presence of an obvious intracranial space-occupying lesion Marked brain atrophy due to stroke, trauma, or similar causes History of surgical treatment for brain disease (excluding minor procedures such as surgery for chronic subdural hematoma) Determined to be unsuitable for study participation due to comorbid systemic diseases (e.g., heart failure, respiratory failure, hepatic failure, renal failure, cancer) Considered inappropriate for inclusion by the principal investigator or co-investigators

Design outcomes

Primary

Measure	Time frame
The change in the modified Rankin Scale score (mRS) from baseline to one-year post-surgery in the VAS group compared to the VPS + LPS group.	—

Secondary

Measure	Time frame
The change in the mRS score from baseline to one-year post-surgery in the VAS group compared to the VPS group. The change in the mRS score from baseline to one-year post-surgery in the VAS group compared to the LPS group. The change in the mRS score from baseline to three months post-surgery in the VAS group compared to the VPS + LPS group. The occurrence of adverse events at three months and one-year post-surgery in the VAS group compared to the VPS + LPS group. The evaluation items that influenced treatment decisions in surgical cases (Group 1) versus non-surgical cases (Group 2).	—

Measure

Time frame

The change in the mRS score from baseline to one-year post-surgery in the VAS group compared to the VPS group. The change in the mRS score from baseline to one-year post-surgery in the VAS group compared to the LPS group. The change in the mRS score from baseline to three months post-surgery in the VAS group compared to the VPS + LPS group. The occurrence of adverse events at three months and one-year post-surgery in the VAS group compared to the VPS + LPS group. The evaluation items that influenced treatment decisions in surgical cases (Group 1) versus non-surgical cases (Group 2).

—

Contacts

Public ContactEriko Okumura

Nagoya University Graduate School of Medicine

okumura.eriko.n4@f.mail.nagoya-u.ac.jp+81-52-744-2353

Outcome results