About this trial
This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH).
The neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol.
The primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult
Suspected iNPH (= at least 1/3 of the triad symptoms + ventriculomegaly on brain imaging)
Hospitalised at Tours University Hospital for 'hydrocephalus assessment'
Patient who has provided written and signed consent
Disqualifiers
Patients already fitted with a CSF shunting system (VPS)
Suspicion of obstructive hydrocephalus (aqueduct stenosis, tumour, etc.)
Patients under legal protection (guardianship, curatorship, judicial protection).
Trial population
Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Clinical improvement
Clinical improvement at 12 months in patients who undergo CSF shunt surgery (ventriculoperitoneal shunt, VPS). Clinical improvement will be defined as cognitive improvement at 12 months and/or gait improvement at 12 months. * Cognitive improvement: improvement in at least two cognitive tests. Improvement in a single test will be defined as an increase ≥ 1 standard deviation between the baseline pre-lumbar puncture (pre-LP) speech therapy evaluation and the 12-month postoperative assessment. * Gait improvement: improvement in the Get Up and Go test and/or the 10-meter walk test (10MWT) between baseline and the 12-month postoperative assessment.
Secondary outcomes
Mattis Dementia Rating Scale score (MDRS)
Detailed speech therapy (neuropsychological) assessment: Mattis Dementia Rating Scale score (/144)
Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)
Detailed speech therapy (neuropsychological) assessment: WAIS-IV - Coding, Digit Span Forward, Digit Span Backward; Verbal fluency - literal and categorical; Trail Making Test A - duration (s) and errors; Rey-Osterrieth Complex Figure - copy duration (s) and copy score (/36); Rey Word List score (/15).
Get Up and Go test (s)
Detailed physiotherapy (motor) assessment: Get Up and Go test (s); Tinetti test (/28)
10-meter walk test
Detailed physiotherapy (motor) assessment: 10-meter walk test (10MWT) (s).
Sponsors and contacts
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