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

April 29, 2026 updated by: University Hospital, Tours

Contribution of Cerebral Pulsatility Assessment by Transcranial Ultrasound to the Decision-making for Cerebrospinal Fluid Shunting in Patients With Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study

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."

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This will be a prospective, single-center cohort study including patients with suspected idiopathic normal pressure hydrocephalus (iNPH). Eligibility will require fulfillment of inclusion criteria and confirmation of non-opposition after written informed consent procedures.

All patients will undergo transcranial pulse imaging (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization. Operated patients will have a second TPI assessment at 12 months post-surgery, while non-operated patients will undergo repeat TPI 12 months after baseline. Ultrasound assessments will be integrated into the standard hydrocephalus work-up.

The decision to perform cerebrospinal fluid (CSF) shunting will be made by the neurosurgical team blinded to ultrasound findings and based solely on standard clinical and radiological criteria. Baseline clinical (demographics, vascular risk factors, cognitive/gait/urinary symptoms, neurological history) and radiological variables (ventricular volume, Evans index, callosal angle, DESH, Radscale) will be collected.

During hospitalization, gait and cognitive function will be evaluated before and 48 hours after lumbar puncture. TPI will provide two indices of cerebral pulsatility: mean brain tissue pulsatility (MeanBTP) and maximal brain tissue pulsatility (MaxBTP), expressed as peak amplitude, peak amplitude mean, and root mean square.

Follow-up will include standardized clinical and radiological assessments. Non-operated patients will be evaluated at 12 months. Operated patients will be seen at 2 months and 12 months postoperatively, with documentation of complications, shunt valve settings, ventricular volume changes, and subdural collections.

Statistical analyses will be performed using STATA v11 (StataCorp, USA). Continuous variables will be expressed as means ± SD or medians; categorical variables as percentages. Normality will be assessed with the Kolmogorov-Smirnov test, and variance equality with F-test. Comparisons will use Student's t-test, chi-square, or Fisher's exact test as appropriate. Cox proportional hazards regression will be applied for multivariable analysis. P < 0.05 will be considered significant.

The primary objective will be to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) measured prior to subtractive lumbar puncture will be significantly higher in patients who show clinical improvement 12 months after cerebrospinal fluid (CSF) shunting compared with those who do not, with a type I error risk (alpha) of 0.05.

The secondary objectives will be to correlate cerebral pulsatility (measured by transcranial pulse imaging, TPI) with functional indices of iNPH and CSF shunting outcomes, including: speech therapy evaluation, physiotherapy-based gait assessment, global neurological disability, ventricular volume, and shunt valve opening pressure.

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"

Description

Inclusion Criteria:

  • 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

Non-inclusion criteria

  • Individuals who objected to data processing
  • Walking assessment by the physiotherapy team impossible AND cognitive assessment by the speech therapy team impossible

Exclusion criteria

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients improved after CSF shunting surgery
patients not improved after CSF shunting surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 12 months

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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mattis Dementia Rating Scale score (MDRS)
Time Frame: 12 months
Detailed speech therapy (neuropsychological) assessment: Mattis Dementia Rating Scale score (/144)
12 months
Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)
Time Frame: 12 months
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).
12 months
Get Up and Go test (s)
Time Frame: 12 months
Detailed physiotherapy (motor) assessment: Get Up and Go test (s); Tinetti test (/28)
12 months
10-meter walk test
Time Frame: 12 months
Detailed physiotherapy (motor) assessment: 10-meter walk test (10MWT) (s).
12 months
Reduction in modified Rankin Scale score (≤ 1 point compared with baseline) at 12 months
Time Frame: 12 months
Global neurological disability assessment: modified Rankin Scale (/6).
12 months
Reduction in ventricular volume (total ventricular volume and third ventricular volume) at 12 months
Time Frame: 12 months
Ventricular volume: measurement of total cerebral ventricular volume (mm³) and third ventricle volume (mm³) using a semi-automated technique with ITK-SNAP 4.2.0®.
12 months
Shunt valve opening pressure (mmH₂O) at 12 months
Time Frame: 12 months
Shunt valve opening pressure: opening pressure value (mmH₂O) at 12 months postoperatively
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Ilyess ZEMMOURA, Pr, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DR250159 - HYDROPULSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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