Idiopathic Normal Pressure Hydrocephalus (INPH)
Conditions
Brief 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.
Interventions
PROCEDUREventriculoperitoneal shunt surgery under general anesthesia
ventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia
PROCEDURElumbar-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
Institute for Clinical Effectiveness, Japan
Nadogaya Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in timed up and go test score | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Delirium Screening Checklist score | 24 hours | 0-8 scale (0 best and 8 worst) |
| 10% or greater improvement in the timed up and go score | 3 months | — |
| Change in timed up and go score | 1 month | — |
| Change in average walking speed measured by the 10-meter walk test | 3 months | — |
| Change in Tinetti scale score | 3 months | Tinetti scale score is 0-28 scale (28 best and 0 worst) |
| Change in modified Rankin Scale score | 3 months | modified Rankin Scale score 0-6 (0 completely independent and 6 death) |
| Change in Overactive Bladder Questionnaire score | 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. |
| Change in Mini-Mental State Exam scores | 3 months | Mini-Mental State Exam scores ranges 0-30 (30 best and 0 worst) |
| Change in Montreal Cognitive Assessment--Japanese Version scores | 3 months | Montreal Cognitive Assessment--Japanese Version scores ranges 0-30 (30 best and 0 worst) |
| Change in 5-level EQ-5D version (EQ-5D-5L) | 3 months | 0-1 (0 worst and 1 best quality of life) |
| Change in 5-level EuroQoL 5D (VAS) | 3 months | 0-100 (0 worst and 100 best quality of life) |
| Days from surgery to discharge | 3 months | — |
| Days of ambulation after surgery | 7 days | — |
Countries
Japan
Contacts
STUDY_CHAIRTakeshi Morimoto, MD, PhD, MPH
Hyogo Medical University
Outcome results
None listed