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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
• Intervention / Treatment: Procedure: ventriculoperitoneal shunt surgery under general anesthesia; Procedure: lumbar-peritoneal shunt procedure under local anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yasuaki Inoue, MD, PhD; Phone Number: +81-4-7167-8336; Email: inoue.yasuaki@gmail.com
• Study Contact Backup: Name: Ryo Oike, MD; Phone Number: +81-4-7167-8336; Email: ryo.st2b@gmail.com

Study Locations

• Japan
  • Chiba
    • Kashiwa, Chiba, Japan, 277-0084
      • Nadogaya Hospital
      • Contact: Yasuaki Inoue, MD, PhD; Phone Number: +81-4-7167-8336; Email: inoue.yasuaki@gmail.com
      • Contact: Ryo Oike, MD; Phone Number: +81-4-7167-8336; Email: ryo.st2b@gmail.com
      • Principal Investigator: yasuaki Inoue, MD, PhD
      • Sub-Investigator: Ryo Oike, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ventriculoperitoneal shunt surgery under general anesthesia (GA-VPS group)	Procedure: ventriculoperitoneal shunt surgery under general anesthesia; ventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia
Active Comparator: lumbar-peritoneal shunt surgery under local anesthesia (LA-LPS group)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in timed up and go test score	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Delirium Screening Checklist score	0-8 scale (0 best and 8 worst)	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
Change in average walking speed measured by the 10-meter walk test		3 months
Change in Tinetti scale score	Tinetti scale score is 0-28 scale (28 best and 0 worst)	3 months
Change in modified Rankin Scale score	modified Rankin Scale score 0-6 (0 completely independent and 6 death)	3 months
Change in Overactive Bladder Questionnaire score	Overactive Bladder Questionnaire score has two components of Symptom Bother Scale and HRQoL Scale. Symptom Bother Scale: The 8 items are scored from 1 ("Not at all") to 6 ("A very great deal"). The scores are then summed to produce a total score ranging from 8 to 48, where higher scores indicate greater symptom bother. HRQoL Scale: The 25 items are scored from 1 ("All of the time" / "Extremely") to 6 ("None of the time" / "Not at all"). Importantly, these items are reverse-scored before being summed. The total and subscale scores are then transformed to a 0-100 scale. On this scale, higher scores reflect a better health-related quality of life.	3 month
Change in Mini-Mental State Exam scores	Mini-Mental State Exam scores ranges 0-30 (30 best and 0 worst)	3 months
Change in Montreal Cognitive Assessment--Japanese Version scores	Montreal Cognitive Assessment--Japanese Version scores ranges 0-30 (30 best and 0 worst)	3 months
Change in 5-level EQ-5D version (EQ-5D-5L)	0-1 (0 worst and 1 best quality of life)	3 months
Change in 5-level EuroQoL 5D (VAS)	0-100 (0 worst and 100 best quality of life)	3 months
Days from surgery to discharge		3 months
Days of ambulation after surgery		7 days

Other Outcome Measures

Outcome Measure	Time Frame
All-cause deaths	3 months
All-cause deaths	12 months
Development of chronic subdural hematoma (hematoma thickness ≥10 mm)	3 months
Surgery for subdural hematoma	3 months
Clinical symptoms caused by shunt surgery (orthostatic headache, seizures, neuropathic pain in the lower limbs, low back pain, falls)	3 months
Device infection	12 months
Shunt malfunction (shunt valve obstruction, shunt valve reversal, lumbar catheter displacement, lumbar catheter rupture, abdominal catheter displacement, abdominal catheter rupture, etc.)	12 months
Systemic complications (vomiting, pneumonia, deep vein thrombosis, pulmonary embolism)	3 months
Stroke (cerebral infarction, intracerebral hemorrhage)	12 months

Collaborators and Investigators

• Sponsor: Institute for Clinical Effectiveness, Japan
• Collaborators: Nadogaya Hospital
• Investigators: Study Chair: Takeshi Morimoto, MD, PhD, MPH, Hyogo Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ICE_2026_01R; 5246 (Other Identifier: Hyogo Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No