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NCT Number: NCT07447479

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

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Key information

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ventriculoperitoneal shunt surgery under general anesthesia

Procedure

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

lumbar-peritoneal shunt procedure under local anesthesia

Procedure

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 outcomes

  1. Change in timed up and go test score

    Time frame: 3 months

Secondary outcomes

  1. Intensive Care Delirium Screening Checklist score

    Time frame: 24 hours

    0-8 scale (0 best and 8 worst)

  2. 10% or greater improvement in the timed up and go score

    Time frame: 3 months

  3. Change in timed up and go score

    Time frame: 1 month

  4. Change in timed up and go score

    Time frame: 6 months

  5. Change in timed up and go score

    Time frame: 12 months

  6. Change in average walking speed measured by the 10-meter walk test

    Time frame: 3 months

  7. Change in Tinetti scale score

    Time frame: 3 months

    Tinetti scale score is 0-28 scale (28 best and 0 worst)

  8. Change in modified Rankin Scale score

    Time frame: 3 months

    modified Rankin Scale score 0-6 (0 completely independent and 6 death)

  9. Change in Overactive Bladder Questionnaire score

    Time frame: 3 month

    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.

  10. Change in Mini-Mental State Exam scores

    Time frame: 3 months

    Mini-Mental State Exam scores ranges 0-30 (30 best and 0 worst)

  11. Change in Montreal Cognitive Assessment--Japanese Version scores

    Time frame: 3 months

    Montreal Cognitive Assessment--Japanese Version scores ranges 0-30 (30 best and 0 worst)

  12. Change in 5-level EQ-5D version (EQ-5D-5L)

    Time frame: 3 months

    0-1 (0 worst and 1 best quality of life)

  13. Change in 5-level EuroQoL 5D (VAS)

    Time frame: 3 months

    0-100 (0 worst and 100 best quality of life)

  14. Days from surgery to discharge

    Time frame: 3 months

  15. Days of ambulation after surgery

    Time frame: 7 days

Other outcomes

  1. All-cause deaths

    Time frame: 3 months

  2. All-cause deaths

    Time frame: 12 months

  3. Development of chronic subdural hematoma (hematoma thickness ≥10 mm)

    Time frame: 3 months

  4. Surgery for subdural hematoma

    Time frame: 3 months

  5. Clinical symptoms caused by shunt surgery (orthostatic headache, seizures, neuropathic pain in the lower limbs, low back pain, falls)

    Time frame: 3 months

  6. Device infection

    Time frame: 12 months

  7. Shunt malfunction (shunt valve obstruction, shunt valve reversal, lumbar catheter displacement, lumbar catheter rupture, abdominal catheter displacement, abdominal catheter rupture, etc.)

    Time frame: 12 months

  8. Systemic complications (vomiting, pneumonia, deep vein thrombosis, pulmonary embolism)

    Time frame: 3 months

  9. Stroke (cerebral infarction, intracerebral hemorrhage)

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ryo Oike, MD

CONTACT

[email protected]

+81-4-7167-8336

Yasuaki Inoue, MD, PhD

CONTACT

[email protected]

+81-4-7167-8336

Sponsors and collaborators

Lead sponsor

Institute for Clinical Effectiveness, Japan

Other

Collaborators

  • Nadogaya Hospital

Registry information

Official study title

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

Acronym: FLOURISH

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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