Idiopathic Normal Pressure Hydrocephalus
Conditions
Interventions
To assess an incidence of one point or more improvement on modified Rankin scale at 3 months after waiting with rehabilitation in idiopathic normal pressure hydrocephalus
To assess an incidence of one
Sponsors
Japan Society of Normal Pressure Hydrocephalus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 60 - 85 years old 2)one or more of NPH triad (gait, cognition, urination) 3)ventriculomegaly (Evans index > 0.3) 4)high convexity tightness in coronal MRI 5)idiopathic
Exclusion criteria
Exclusion criteria: 1) unpromising improvement due to motor, visceral or psychiatric disorders 2)association with malignancy or difficulty in one-year follow-up 3)hemorrhagic diathesis, coagulopathy or hemorrhagic disorders(intracerebral hemorrhage, subarachnoid hemorrhage) 4)hepatic failure 5)renal failure requiring artificial dialysis 6)planned major surgery during the study period 7)on medication with anticoagulant or antiplatelet agents without interruption 8)history of major abdominal surgery or lumbago 9)unsuitable by the decision of doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| More than 1 level improvement on modified Rankin scale 3 months after randomization, and prevalence of safety issues | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improvement of gait, cognitive, and urinary dysfunction 3 months after randomization measured with the iNPH grading scale, 3-meter timed up and go test, frontal assessment battery, and so on 2) More than 1 level improvement on modified Rankin scale 1 year after cerebrospinal fluid shunt 3) Cerebral blood flow measurement by IMP-SPECT | — |
Countries
Japan
Outcome results
None listed