Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
NCT ID: NCT07285928
Last Updated: 2025-12-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
110 participants
Study Classification
OBSERVATIONAL
Study Start Date
2026-01-31
Study Completion Date
2029-01-31
Brief Summary
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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."
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."
Detailed Description
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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.
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.
Conditions
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Brain Pulsatility
Idiopathic Normal Pressure Hydrocephalus (INPH)
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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patients improved after CSF shunting surgery
No interventions assigned to this group
patients not improved after CSF shunting surgery
No interventions assigned to this group
Eligibility Criteria
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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
* Individuals who objected to data processing
* Walking assessment by the physiotherapy team impossible AND cognitive assessment by the speech therapy team impossible
* 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
* 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).
* Suspicion of obstructive hydrocephalus (aqueduct stenosis, tumour, etc.)
* Patients under legal protection (guardianship, curatorship, judicial protection).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Tours
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ilyess ZEMMOURA, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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university hospital, Tours
Tours, , France
Site Status
Countries
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France
Central Contacts
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Facility Contacts
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References
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Bradley WG Jr, Scalzo D, Queralt J, Nitz WN, Atkinson DJ, Wong P. Normal-pressure hydrocephalus: evaluation with cerebrospinal fluid flow measurements at MR imaging. Radiology. 1996 Feb;198(2):523-9. doi: 10.1148/radiology.198.2.8596861.
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Hamilton RB, Scalzo F, Baldwin K, Dorn A, Vespa P, Hu X, Bergsneider M. Opposing CSF hydrodynamic trends found in the cerebral aqueduct and prepontine cistern following shunt treatment in patients with normal pressure hydrocephalus. Fluids Barriers CNS. 2019 Jan 22;16(1):2. doi: 10.1186/s12987-019-0122-0.
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Other Identifiers
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DR250159 - HYDROPULSE
Identifier Type: -
Identifier Source: org_study_id