Idiopathic Normal Pressure Hydrocephalus (INPH)Phase 4FLOURISHNCT07447479
Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial
A Phase 4 study testing ventriculoperitoneal shunt surgery under general anesthesia and lumbar-peritoneal shunt procedure under local anesthesia in people with Idiopathic Normal Pressure Hydrocephalus (INPH), run by Institute for Clinical Effectiveness, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (INPH)
- What is being tested?
- ventriculoperitoneal shunt surgery under general anesthesia and lumbar-peritoneal shunt procedure under local anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2026to 31 Mar 2031
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- ventriculoperitoneal shunt surgery under general anesthesia, lumbar-peritoneal shunt procedure under local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventriculoperitoneal shunt surgery under general anesthesiaProcedure or surgery
ventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia
lumbar-peritoneal shunt procedure under local anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ventriculoperitoneal shunt surgery under general anesthesia (GA-VPS group) | Active comparator | Not described Receives: Procedure: ventriculoperitoneal shunt surgery under general anesthesia |
| lumbar-peritoneal shunt surgery under local anesthesia (LA-LPS group) | Active comparator | Not described Receives: Procedure: lumbar-peritoneal shunt procedure under local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in timed up and go test score
Measured: 3 months
Secondary outcomes (15)
Intensive Care Delirium Screening Checklist score
0-8 scale (0 best and 8 worst)
Measured: 24 hours
10% or greater improvement in the timed up and go score
Measured: 3 months
Change in timed up and go score
Measured: 1 month
Change in timed up and go score
Measured: 6 months
Change in timed up and go score
Measured: 12 months
Change in average walking speed measured by the 10-meter walk test
Measured: 3 months
Change in Tinetti scale score
Tinetti scale score is 0-28 scale (28 best and 0 worst)
Measured: 3 months
Change in modified Rankin Scale score
modified Rankin Scale score 0-6 (0 completely independent and 6 death)
Measured: 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.
Measured: 3 month
Change in Mini-Mental State Exam scores
Mini-Mental State Exam scores ranges 0-30 (30 best and 0 worst)
Measured: 3 months
Change in Montreal Cognitive Assessment--Japanese Version scores
Montreal Cognitive Assessment--Japanese Version scores ranges 0-30 (30 best and 0 worst)
Measured: 3 months
Change in 5-level EQ-5D version (EQ-5D-5L)
0-1 (0 worst and 1 best quality of life)
Measured: 3 months
Change in 5-level EuroQoL 5D (VAS)
0-100 (0 worst and 100 best quality of life)
Measured: 3 months
Days from surgery to discharge
Measured: 3 months
Days of ambulation after surgery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
Why it stopped: Before the enrolment of participants, the principal investigator was fired, and the study site did not allow the continuation of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Normal Pressure Hydrocephalus (INPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Nadogaya Hospital
- Responsible party
- Sponsor
- Investigators
- Takeshi Morimoto, MD, PhD, MPH, Study chair, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447479
- Sponsor's protocol ID
- ICE_2026_01R
- Other IDs
- 5246
- Acronym
- FLOURISH
- Status last verified
- Jul 2026
- First submitted
- 22 Feb 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes After Lumbopenitoneal Shunt Placement Under Local Anesthesia for Patients With Idiopathic Normal Pressure Hydrocephalus Trial
- ClinicalTrials.gov ID
- NCT07447479
- Acronym / sponsor ID
- FLOURISH / ICE_2026_01R
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Before the enrolment of participants, the principal investigator was fired, and the study site did not allow the continuation of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness, JapanUniversity, hospital or other
- Collaborators
- Nadogaya Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventriculoperitoneal shunt surgery under general anesthesiaventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia | Procedure or surgery | ventriculoperitoneal shunt surgery under general anesthesia (GA-VPS group) |
| lumbar-peritoneal shunt procedure under local anesthesiaPentazocine and midazolam are administered intravenously to induce conscious sedation, and a lumbar-peritoneal shunt procedure is performed using local infiltration anesthesia with 1% lidocaine. | Procedure or surgery | lumbar-peritoneal shunt surgery under local anesthesia (LA-LPS group) |
Primary outcome
Change in timed up and go test score
Time frame: 3 months
15 secondary outcomes
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
Change in 5-level EuroQoL 5D (VAS)
Time frame: 3 months
Days from surgery to discharge
Time frame: 3 months
Days of ambulation after surgery
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Morimoto, MD, PhD, MPH study chair
Hyogo Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ventriculoperitoneal shunt surgery under general anesthesia and lumbar-peritoneal shunt procedure under local anesthesia in people with Idiopathic Normal Pressure Hydrocephalus (INPH), run by Institute for Clinical Effectiveness, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in timed up and go test score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.