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

NCT07447479 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Idiopathic Normal Pressure Hydrocephalus (INPH)

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.

Sponsors & Collaborators

  • Nadogaya Hospital

    collaborator UNKNOWN

  • Institute for Clinical Effectiveness, Japan

    lead OTHER

Principal Investigators

  • Takeshi Morimoto, MD, PhD, MPH · Hyogo Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-04-30
Completion
2031-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07447479 on ClinicalTrials.gov