2. Summary of key characteristics of iNPH randomised controlled trials.
Study | Study design | Location | Blinding | Participants | CSF testing entry criteria | Radiological criteria | Number randomised/shunted | Intervention | Published in medical literature |
Tisell 2011 | 1‐arm, cross‐over RCT | Single centre, Sweden | Double (participant & assessor) | Symptomatic iNPH > 60 years with Binswanger's | Negative CSFTT and LIS | Evans index > 0.3, Binswanger's disease* | 14/14 | VP shunt | Full |
Toma 2016 | 1‐arm, cross‐over RCT | Single centre, UK | Double (participant & assessor) | Symptomatic iNPH > 60 years | Positive ELD | Evans index > 0.3 | 15/15 | VP shunt | Partial |
Kazui 2015 | 1‐arm, cross‐over RCT | Multicentre, Japan | Not blinded | Symptomatic iNPH > 60 years | Normal CSF opening pressure | Evans index > 0.3 and high‐convexity and medial subarachnoid space tightness | 93/88 | LP shunt | Full |
Luciano 2023 | 1‐arm, cross‐over RCT | Multicentre: USA, Canada, Sweden | Double (participant & assessor) | Symptomatic iNPH > 60 years | Positive CSFTT or ELD | Evans index > 0.3 | 18/18 | VP shunt | Full |
Abbreviations: CSF: cerebrospinal fluid; CSFTT: CSF tap‐test; ELD: external lumbar drain; iNPH: idiopathic normal pressure hydrocephalus; LIS: lumbar infusion study; LP: lumboperitoneal; RCT: randomised controlled trial; VP: ventriculoperitoneal
*Binswanger's disease defined by a score of 2 to 3 on Wahlund scale.