NCT07447479

Brief Summary

This study is a prospective observational registry study that enrolls all patients aged 60 years or older suspected of having idiopathic normal pressure hydrocephalus based on the Third Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. From the cohort registered, patients judged to be candidates for surgery based on the 3rd Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. These patients will be randomized 1:1 to undergo either ventriculoperitoneal shunt surgery under general anesthesia or lumbar peritoneal shunt surgery under local anesthesia. A randomized clinical trial would attest the non-inferiority of lumbar peritoneal shunt surgery under local anesthesia compared to ventriculoperitoneal shunt surgery under general anesthesia regarding the improvement in timed up-and-go test scores at 3 months post-surgery relative to pre-surgery levels.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for phase_4

Timeline
60mo left

Started Apr 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Mar 2031

First Submitted

Initial submission to the registry

February 22, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

February 22, 2026

Last Update Submit

February 26, 2026

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Outcome Measures

Primary Outcomes (1)

  • Change in timed up and go test score

    3 months

Secondary Outcomes (15)

  • Intensive Care Delirium Screening Checklist score

    24 hours

  • 10% or greater improvement in the timed up and go score

    3 months

  • Change in timed up and go score

    1 month

  • Change in timed up and go score

    6 months

  • Change in timed up and go score

    12 months

  • +10 more secondary outcomes

Other Outcomes (9)

  • All-cause deaths

    3 months

  • All-cause deaths

    12 months

  • Development of chronic subdural hematoma (hematoma thickness ≥10 mm)

    3 months

  • +6 more other outcomes

Study Arms (2)

ventriculoperitoneal shunt surgery under general anesthesia (GA-VPS group)

ACTIVE COMPARATOR
Procedure: ventriculoperitoneal shunt surgery under general anesthesia

lumbar-peritoneal shunt surgery under local anesthesia (LA-LPS group)

ACTIVE COMPARATOR
Procedure: lumbar-peritoneal shunt procedure under local anesthesia

Interventions

ventriculoperitoneal shunt surgery under general anesthesiaPROCEDURE

ventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia

ventriculoperitoneal shunt surgery under general anesthesia (GA-VPS group)
lumbar-peritoneal shunt procedure under local anesthesiaPROCEDURE

Pentazocine and midazolam are administered intravenously to induce conscious sedation, and a lumbar-peritoneal shunt procedure is performed using local infiltration anesthesia with 1% lidocaine.

lumbar-peritoneal shunt surgery under local anesthesia (LA-LPS group)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Probable iNPH patients
  • Age 60 years or older at the time of the tap test
  • Patients capable of performing the Timed Up and Go test
  • Patients assignable within 2 weeks (14 days) of obtaining RCT consent
  • Patients capable of undergoing shunt surgery within 1 month (30 days) of assignment
  • Patients capable of follow-up at the assigned facility or referring facility for 12 months after assignment
  • Patients for whom informed consent was obtained

You may not qualify if:

  • Patients deemed unsuitable for lumbar-abdominal shunt surgery due to advanced degeneration of the lumbar spine and spinal canal, etc.
  • Patients deemed unsuitable for abdominal shunt surgery due to a history of multiple open abdominal surgeries, a history of severe intra-abdominal infection, etc.
  • Other patients deemed unsuitable by the attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nadogaya Hospital

Kashiwa, Chiba, 277-0084, Japan

Location

Study Officials

  • Takeshi Morimoto, MD, PhD, MPH

    Hyogo Medical University

    STUDY CHAIR

Central Study Contacts

Yasuaki Inoue, MD, PhD

CONTACT

+81-4-7167-8336inoue.yasuaki@gmail.com

Ryo Oike, MD

CONTACT

+81-4-7167-8336ryo.st2b@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2026

First Posted

March 3, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

March 31, 2031

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)