JMIR Publications

ABSTRACT

Background:

Idiopathic normal pressure hydrocephalus is an age-related condition characterized by cerebrospinal fluid accumulation and ventricular enlargement, leading to cognitive decline, gait disturbance, and urinary incontinence. Although shunt surgery is the primary treatment, the optimal surgical strategy remains uncertain, and procedure selection is often not tailored to individual patient characteristics. Notably, no prospective study has directly compared the three major shunt techniques: ventriculoperitoneal, lumboperitoneal, and ventriculoatrial shunts.

Objective:

This multicenter prospective observational study aims to generate high-quality clinical evidence by evaluating the effectiveness and safety of these three surgical options in real-world settings.

Methods:

Patients suspected of having this condition will be enrolled based on characteristic symptoms and imaging findings, with a spinal tap test recommended but not mandatory. Eligible patients will undergo one of the three surgical procedures.

Results:

Based on recent data from 11 collaborating institutions in Japan, we estimate 278 cases: 188 surgical, 100 non-surgical, and 10 dropouts. Clinical outcomes will be assessed at baseline, after the tap test (if performed), and at 1 week, 3 months, and 12 months postoperatively. Analyses will explore associations between outcomes and surgical methods, patient background, and imaging features.

Conclusions:

Japan is well-placed to lead this comparative study with its extensive experience in diagnosing and treating this disease. The findings are expected to provide practical guidance for individualized surgical decision-making and contribute to the global consensus on optimal treatment strategies. Clinical Trial: Japan Registry of Clinical Trials (jRCT1040250005); https://jrct.mhlw.go.jp/re/reports/detail/96348