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. 2024 Aug 6;2024(8):CD014923. doi: 10.1002/14651858.CD014923.pub2

Toma 2016.

Study characteristics
Methods Study design: 1‐arm, cross‐over randomised controlled trial, assessor and participant blinded
Number randomised: 15
Exclusions: all participants had the intended intervention. 1 withdrew consent following surgery in the inactive group.
Length of follow‐up: 12 months
How data were handled: modified intention‐to‐treat
Participants Country: United Kingdom
Setting: single centre
Baseline characteristics:
Immediate‐shunt group
  • Mean age in years: 75

  • Female: 25%


Delayed‐shunt group
  • Mean age in years: 74.4

  • Female: 14%


Number of Hakim symptoms: gait + 1 other
Inclusion criteria:
  • Diagnosis of probable iNPH (Relkin guidelines)

  • Clear improvement of walking speed following 72 hours of extended lumbar drainage

  • Clinical findings of gait/balance disturbance, plus at least 1 other area of impairment in cognition, urinary symptoms, or both

  • A brain imaging study (CT or MRI) must show evidence of ventricular enlargement (Evans index > 0.3)

  • CSF opening pressure < 18 mmHg

  • No evidence of an antecedent event such as head trauma, intracerebral haemorrhage, meningitis, or other known causes of secondary hydrocephalus

  • No other neurological, psychiatric, or general medical conditions that are sufficient to explain the presenting symptoms


Exclusion criteria:
  • Evidence of concomitant Alzheimer’s disease or vascular dementia

Interventions Intervention 1: active VP shunt
Intervention 2: initially inactive VP shunt changed to active at 3 months
Outcomes Primary outcome:
  • Improvement in gait, as determined by the timed walking test


Secondary outcomes:
  • Improvement in mental function, as determined by neuropsychological testing

  • Improvement in urinary function

  • Incidence of complications

Notes Sources of support: nil
Possible conflicts of interest: Toma PhD funded by B Braun.

10 MWT: 10‐metre walk test
CSF: cerebrospinal fluid
CSFTT: cerebrospinal fluid tap test
CT: computed tomography
FAB: frontal assessment battery
iNPH: idiopathic normal pressure hydrocephalus
iNPHGS: idiopathic normal pressure hydrocephalus grading scale
LP: lumboperitoneal
MMSE: Mini‐Mental State Examination
MoCA: Montreal Cognitive Assessment
MRI: magnetic resonance imaging
mRS: modified Rankin Scale
n/a: not available
NPH: normal pressure hydrocephalus
SD: standard deviation
SSS‐WAIS‐III: Symbol Search subset of Wechsler Adult Intelligence Scale, Third Edition
TMT‐A: trail making test A
TUG: timed up‐and‐go test
VP: ventriculoperitoneal