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Not yet recruiting NCT07447479

Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial

Phase IV Interventional Idiopathic Normal Pressure Hydrocephalus (INPH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ventriculoperitoneal shunt surgery under general anesthesia, lumbar-peritoneal shunt procedure under local anesthesia.
Who it may be relevant to
Registry conditions: Idiopathic Normal Pressure Hydrocephalus (INPH). Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Functional Outcomes After Lumbopenitoneal Shunt Placement Under Local Anesthesia for Patients With Idiopathic Normal Pressure Hydrocephalus Trial

Overview

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.

Interventions

  • Procedure ventriculoperitoneal shunt surgery under general anesthesia
    ventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia
  • Procedure lumbar-peritoneal shunt procedure under local anesthesia
    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.

Primary outcome measures

  • Change in timed up and go test score [Time frame: 3 months]
Secondary outcome measures (12)
  • Intensive Care Delirium Screening Checklist score [Time frame: 24 hours]
  • 10% or greater improvement in the timed up and go score [Time frame: 3 months]
  • Change in timed up and go score [Time frame: 1 month]
  • Change in timed up and go score [Time frame: 6 months]
  • Change in timed up and go score [Time frame: 12 months]
  • Change in average walking speed measured by the 10-meter walk test [Time frame: 3 months]
  • Change in Tinetti scale score [Time frame: 3 months]
  • Change in modified Rankin Scale score [Time frame: 3 months]
  • Change in Overactive Bladder Questionnaire score [Time frame: 3 month]
  • Change in Mini-Mental State Exam scores [Time frame: 3 months]
  • Change in Montreal Cognitive Assessment--Japanese Version scores [Time frame: 3 months]
  • Change in 5-level EQ-5D version (EQ-5D-5L) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Nadogaya Hospital — Kashiwa

Identifiers

NCT: NCT07447479 · ICE_2026_01R · 5246

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗