Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

110 Participants
are grouped into 2 trial groups

Sponsors and collaborators