Study A (Retrospective, US) | Study B (Prospective, US) | Study C (Retrospective, EU) | Study D (Prospective, EU) | |
---|---|---|---|---|
N | 7 | 11 | 15 | 17 |
Hospital setting | University of Pennsylvania Philadelphia, PA, USA | Johns Hopkins University Baltimore, MD, USA | • University of Eastern Finland Kuopio, Finland | 4 neurosurgical units in Finland: |
• Same 2 centers as in Study C | ||||
• Turku University Turku, Finland | • Helsinki University (Helsinki) | |||
• Seinajoki Central Hospital (Seinajoki) | ||||
Patients | Retrospectively identified from database. | Patients scheduled for shunt placement were contacted. | Patients had previously undergone ICP monitoring and R frontal brain biopsy for suspected iNPH. | Patients scheduled for shunt placement were contacted. |
Clinical conduct start/end dates | 21 Dec 2009 | 11 Mar 2010 | 15 Jun 2010 | 31 May 2010 |
02 Jul 2010 | 05 Jan 2011 | 17 Nov 2010 | 16 Dec 2010 | |
Order and timing of Biopsy/PET a,b | Biopsy/PET, 3 to 45 months apart | PET/Biopsy, approximately 8 weeks apart | Biopsy/PET, 8.8 to 38.2 months apart | PET/Biopsy, approximately 3 weeks apart |
Diagnostic criteria for iNPH | Patients who had undergone shunting with concomitant R prefrontal cortical biopsy (most patients from a previous study of the impact of AD pathology on clinical response to shunting [18]). | Patients scheduled for shunt placement for iNPH. | Patients had previously undergone 24-hour ICP monitoring and R frontal cortical biopsy. | CT/MRI findings (enlarged ventricles + obliterated cortical sulci) + at least 2 of the 3 cardinal symptoms (abnormal gait, incontinence, cognitive impairment) + if necessary, positive lumbar tap test or 24-hour ICP recording. |