Brain PulsatilityHYDROPULSENCT07285928
Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
An observational study of Brain Pulsatility and Idiopathic Normal Pressure Hydrocephalus (INPH), run by University Hospital, Tours at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Pulsatility, Idiopathic Normal Pressure Hydrocephalus (INPH)
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
university hospital, Tours
Tours, 37044
Ilyess ZEMMOURA, Pr, 218370813 ext. +33, ilyess.zemmoura@univ-tours.fr
About this study
Official title: 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."
Read the 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.
- Keywords
- transcranial ultrasound, cerebral pulsatility, idiopathic normal pressure hydrocephalus (iNPH),
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients improved after CSF shunting surgery | Not described | |
| patients not improved after CSF shunting surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Mattis Dementia Rating Scale score (MDRS)
Detailed speech therapy (neuropsychological) assessment: Mattis Dementia Rating Scale score (/144)
Measured: 12 months
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).
Measured: 12 months
Get Up and Go test (s)
Detailed physiotherapy (motor) assessment: Get Up and Go test (s); Tinetti test (/28)
Measured: 12 months
10-meter walk test
Detailed physiotherapy (motor) assessment: 10-meter walk test (10MWT) (s).
Measured: 12 months
Reduction in modified Rankin Scale score (≤ 1 point compared with baseline) at 12 months
Global neurological disability assessment: modified Rankin Scale (/6).
Measured: 12 months
Reduction in ventricular volume (total ventricular volume and third ventricular volume) at 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®.
Measured: 12 months
Shunt valve opening pressure (mmH₂O) at 12 months
Shunt valve opening pressure: opening pressure value (mmH₂O) at 12 months postoperatively
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Brain PulsatilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilyess ZEMMOURA, Pr, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285928
- Sponsor's protocol ID
- DR250159 - HYDROPULSE
- Acronym
- HYDROPULSE
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ternifi R, Cazals X, Desmidt T, Andersson F, Camus V, Cottier JP, Patat F, Remenieras JP. Ultrasound measurements of brain tissue pulsatility correlate with the volume of MRI white-matter hyperintensity. J Cereb Blood Flow Metab. 2014 Jun;34(6):942-4. doi: 10.1038/jcbfm.2014.58. Epub 2014 Apr 9.
PubMed 24714033Byram B, Trahey GE, Palmeri M. Bayesian speckle tracking. Part II: biased ultrasound displacement estimation. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Jan;60(1):144-57. doi: 10.1109/TUFFC.2013.2546.
PubMed 23287921LANGFITT TW, KASSELL NF, WEINSTEIN JD. CEREBRAL BLOOD FLOW WITH INTRACRANIAL HYPERTENSION. Neurology. 1965 Aug;15:761-73. doi: 10.1212/wnl.15.8.761. No abstract available.
PubMed 14315301Kucewicz JC, Dunmire B, Giardino ND, Leotta DF, Paun M, Dager SR, Beach KW. Tissue pulsatility imaging of cerebral vasoreactivity during hyperventilation. Ultrasound Med Biol. 2008 Aug;34(8):1200-8. doi: 10.1016/j.ultrasmedbio.2008.01.001. Epub 2008 Mar 12.
PubMed 18336991Kucewicz JC, Dunmire B, Leotta DF, Panagiotides H, Paun M, Beach KW. Functional tissue pulsatility imaging of the brain during visual stimulation. Ultrasound Med Biol. 2007 May;33(5):681-90. doi: 10.1016/j.ultrasmedbio.2006.11.008.
PubMed 17346872Biogeau J, Desmidt T, Dujardin PA, Ternifi R, Eudo C, Vierron E, Remenieras JP, Patat F, Camus V, Constans T. Ultrasound Tissue Pulsatility Imaging Suggests Impairment in Global Brain Pulsatility and Small Vessels in Elderly Patients with Orthostatic Hypotension. J Stroke Cerebrovasc Dis. 2017 Feb;26(2):246-251. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.002. Epub 2016 Nov 25.
PubMed 27894887Desmidt T, Hachemi ME, Remenieras JP, Lecomte P, Ferreira-Maldent N, Patat F, Camus V. Ultrasound Brain Tissue Pulsatility is decreased in middle aged and elderly type 2 diabetic patients with depression. Psychiatry Res. 2011 Jul 30;193(1):63-4. doi: 10.1016/j.pscychresns.2011.01.002. Epub 2011 May 17.
PubMed 21592742Eide PK, Brean A. Intracranial pulse pressure amplitude levels determined during preoperative assessment of subjects with possible idiopathic normal pressure hydrocephalus. Acta Neurochir (Wien). 2006 Nov;148(11):1151-6; discussion 1156. doi: 10.1007/s00701-006-0896-0. Epub 2006 Oct 16.
PubMed 17039303Eide PK. Intracranial pressure parameters in idiopathic normal pressure hydrocephalus patients treated with ventriculo-peritoneal shunts. Acta Neurochir (Wien). 2006 Jan;148(1):21-9; discussion 29. doi: 10.1007/s00701-005-0654-8. Epub 2005 Nov 14.
PubMed 16284706Eide PK, Sorteberg W. Diagnostic intracranial pressure monitoring and surgical management in idiopathic normal pressure hydrocephalus: a 6-year review of 214 patients. Neurosurgery. 2010 Jan;66(1):80-91. doi: 10.1227/01.NEU.0000363408.69856.B8.
PubMed 20023540Baroncini M, Baledent O, Ardi CE, Delannoy VD, Kuchcinski G, Duhamel A, Ares GS, Lejeune JP, Hodel J. Ventriculomegaly in the Elderly: Who Needs a Shunt? A MRI Study on 90 Patients. Acta Neurochir Suppl. 2018;126:221-228. doi: 10.1007/978-3-319-65798-1_45.
PubMed 29492565Bradley 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.
PubMed 8596861Stecco A, Cassara A, Zuccala A, Anoaica MB, Genovese E, Car PG, Panzarasa GP, Guzzardi G, Carriero A. Quantitative analysis of cerebrospinal fluid dynamics at phase contrast cine-MRI: predictivity of neurosurgical "Shunt" responsiveness in patients with idiopathic normal pressure hydrocephalus. J Neurosurg Sci. 2020 Oct;64(5):420-426. doi: 10.23736/S0390-5616.17.04092-9. Epub 2017 Sep 4.
PubMed 28869371Garcia-Armengol R, Domenech S, Botella-Campos C, Goncalves FJ, Menendez B, Teixidor P, Munoz-Narbona L, Rimbau J. Comparison of elevated intracranial pressure pulse amplitude and disproportionately enlarged subarachnoid space (DESH) for prediction of surgical results in suspected idiopathic normal pressure hydrocephalus. Acta Neurochir (Wien). 2016 Nov;158(11):2207-2213. doi: 10.1007/s00701-016-2858-5. Epub 2016 Jun 27.
PubMed 27349896Hamilton 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.
PubMed 30665428
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07285928
- Acronym / sponsor ID
- HYDROPULSE / DR250159 - HYDROPULSE
- Keywords
- transcranial ultrasound, cerebral pulsatility, idiopathic normal pressure hydrocephalus (iNPH),
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients improved after CSF shunting surgery | – | – |
| patients not improved after CSF shunting surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Mattis Dementia Rating Scale score (MDRS)
Time frame: 12 months
Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)
Time frame: 12 months
Get Up and Go test (s)
Time frame: 12 months
10-meter walk test
Time frame: 12 months
Reduction in modified Rankin Scale score (≤ 1 point compared with baseline) at 12 months
Time frame: 12 months
Reduction in ventricular volume (total ventricular volume and third ventricular volume) at 12 months
Time frame: 12 months
Shunt valve opening pressure (mmH₂O) at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 24714033Ternifi R, Cazals X, Desmidt T, Andersson F, Camus V, Cottier JP, Patat F, Remenieras JP. Ultrasound measurements of brain tissue pulsatility correlate with the volume of MRI white-matter hyperintensity. J Cereb Blood Flow Metab. 2014 Jun;34(6):942-4. doi: 10.1038/jcbfm.2014.58. Epub 2014 Apr 9.
- Background: PubMed 23287921Byram B, Trahey GE, Palmeri M. Bayesian speckle tracking. Part II: biased ultrasound displacement estimation. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Jan;60(1):144-57. doi: 10.1109/TUFFC.2013.2546.
- Background: PubMed 14315301LANGFITT TW, KASSELL NF, WEINSTEIN JD. CEREBRAL BLOOD FLOW WITH INTRACRANIAL HYPERTENSION. Neurology. 1965 Aug;15:761-73. doi: 10.1212/wnl.15.8.761. No abstract available.
- Background: PubMed 18336991Kucewicz JC, Dunmire B, Giardino ND, Leotta DF, Paun M, Dager SR, Beach KW. Tissue pulsatility imaging of cerebral vasoreactivity during hyperventilation. Ultrasound Med Biol. 2008 Aug;34(8):1200-8. doi: 10.1016/j.ultrasmedbio.2008.01.001. Epub 2008 Mar 12.
- Background: PubMed 17346872Kucewicz JC, Dunmire B, Leotta DF, Panagiotides H, Paun M, Beach KW. Functional tissue pulsatility imaging of the brain during visual stimulation. Ultrasound Med Biol. 2007 May;33(5):681-90. doi: 10.1016/j.ultrasmedbio.2006.11.008.
- Background: PubMed 27894887Biogeau J, Desmidt T, Dujardin PA, Ternifi R, Eudo C, Vierron E, Remenieras JP, Patat F, Camus V, Constans T. Ultrasound Tissue Pulsatility Imaging Suggests Impairment in Global Brain Pulsatility and Small Vessels in Elderly Patients with Orthostatic Hypotension. J Stroke Cerebrovasc Dis. 2017 Feb;26(2):246-251. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.002. Epub 2016 Nov 25.
- Background: PubMed 21592742Desmidt T, Hachemi ME, Remenieras JP, Lecomte P, Ferreira-Maldent N, Patat F, Camus V. Ultrasound Brain Tissue Pulsatility is decreased in middle aged and elderly type 2 diabetic patients with depression. Psychiatry Res. 2011 Jul 30;193(1):63-4. doi: 10.1016/j.pscychresns.2011.01.002. Epub 2011 May 17.
- Background: PubMed 17039303Eide PK, Brean A. Intracranial pulse pressure amplitude levels determined during preoperative assessment of subjects with possible idiopathic normal pressure hydrocephalus. Acta Neurochir (Wien). 2006 Nov;148(11):1151-6; discussion 1156. doi: 10.1007/s00701-006-0896-0. Epub 2006 Oct 16.
- Background: PubMed 16284706Eide PK. Intracranial pressure parameters in idiopathic normal pressure hydrocephalus patients treated with ventriculo-peritoneal shunts. Acta Neurochir (Wien). 2006 Jan;148(1):21-9; discussion 29. doi: 10.1007/s00701-005-0654-8. Epub 2005 Nov 14.
- Background: PubMed 20023540Eide PK, Sorteberg W. Diagnostic intracranial pressure monitoring and surgical management in idiopathic normal pressure hydrocephalus: a 6-year review of 214 patients. Neurosurgery. 2010 Jan;66(1):80-91. doi: 10.1227/01.NEU.0000363408.69856.B8.
- Background: PubMed 29492565Baroncini M, Baledent O, Ardi CE, Delannoy VD, Kuchcinski G, Duhamel A, Ares GS, Lejeune JP, Hodel J. Ventriculomegaly in the Elderly: Who Needs a Shunt? A MRI Study on 90 Patients. Acta Neurochir Suppl. 2018;126:221-228. doi: 10.1007/978-3-319-65798-1_45.
- Background: PubMed 8596861Bradley 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.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Pulsatility
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Not yet recruitingObservational study
Doppler Ultrasonography Parameters and Mortality in Traumatic Brain Injury
Traumatic Brain Injuries, Brain Injuries,Traumatic
Not yet recruitingObservational study
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruitingObservational study
Transcranial Doppler Evaluation After Endovascular Thrombectomy for Acute Ischemic Stroke (PRECISE-TCD)
Anterior Cerebral Artery Syndrome, Anterior Cerebral Artery Stroke
RecruitingObservational study
Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
Critical Illness, Pediatric Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilyess ZEMMOURA, Pr principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Pulsatility and Idiopathic Normal Pressure Hydrocephalus (INPH), run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilyess ZEMMOURA, Pr (218370813 ext. +33, ilyess.zemmoura@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285928, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.