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AgingCOSTUMNCT01737606

Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

A study testing Fast Cerebral Pulsatility Imaging in people with Aging and Cerebral Pulsatility, run by University Hospital, Tours at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The new technical of ultrasonic exploration of this project purpose to validate the measurement of cerebral pulsatility by a new way called "Fast Cerebral Pulsatility Imaging" (FCPI).This will somehow determine the natural history of cerebral pulsatility during development adult to old age Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Cerebral Pulsatility
What is being tested?
Fast Cerebral Pulsatility Imaging
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteFrance
Study dates
Sep 2012to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient at least 18 years old
  • Informed consent form signed
  • Person affiliated to a medical insurance
  • Male or female
  • No smoking the day of the inclusion
  • Right handed: Edinburgh test ≥0.8 (subjects of phase 2)
  • MMS score ≥ 27 and 5 words score = 10 (subjects of phase 2)
  • Socio-educational level greater than or equal to 8 years of school (subjects of phase 2)

Who cannot join

  • Pregnant women, lactating women or women without reliable contraception
  • Contraindications to IRM for patients with: ocular metallic foreign object; any electronic medical device implanted by irremovable way (pacemakers, neuro-stimulator, cochlear implants ...); metallic heart valve, old heart valves are specially an absolute contraindication because of risk of dysfunction; vascular clips implanted formerly on brain aneurysm
  • Acute medico-surgical condition dating from less than 3 months
  • Neurological and neuro-surgical pathology such as: toxic, infectious or inflammatory encephalopathy, epilepsy, intracranial arteriovenous malformation known, intracranial tumor or hydrocephalus known, operated or no, history of ischemic or hemorrhagic stroke, transient or not
  • Treatments or pathology that could influence the results of the research: heart failure (dyspnea with stage III or IV NYHA) or non-sinus cardiac rhythm, use of central analgesics or psychotropic drugs
  • Psychiatrics disorders of axe 1 of DSM IV, based on MINI (subjects of phase 2)
  • Major subject with a legal protection measure
  • Subject to exclusion period of any other biomedical research

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital of Tours

    Tours, 37044

Other trials in France

About this study

The new technical of ultrasonic exploration of this project purpose to validate the measurement of cerebral pulsatility by a new way called "Fast Cerebral Pulsatility Imaging" (FCPI).This will somehow determine the natural history of cerebral pulsatility during development adult to old age

Read the detailed description

Main objective

Phase 1:

-Study the in-vivo development of ultrasonic method in terms of quality of the acquisitions and intra-operator reproducibility.

Study the ease of positioning in relation to MRI and fusion of MRI and FCPI data via the neuro-navigation system

Phase 2:

-Study the variability of cerebral pulsatility of measured by "Fast Cerebral Pulsatility Imaging" or FCPI with age.

Secondary objectives

  • Compare the results of displacements cartography's and vascular cartography obtained by MRI (especially by Arteriel Spin Labelling = ASL)
  • Compare results of FCPI with results of cognitive tests of aging separating fluid functions (prefrontal) and functions called crystallized; and study the residual effect of age on cognitive tasks and speed of cognitive processing after taking into account the effect of the cerebral pulsatility
  • Compare results of FCPI with electrophysiological measures (PE EEG) describing the attentional control
  • Perform an exploratory analysis to highlight the propagating part of the brain displacement maps
Being tested
Fast Cerebral Pulsatility Imaging
Keywords
Cerebral pulsatility, Fast Cerebral Pulsatility Imaging or FCPI, MRI, Arteriel Spin Labelling, Cognitive tasks, Aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fast Cerebral Pulsatility ImagingDevice

    Also called FCPI

    Cerebral ultrasonic exploration using with neuro-navigation system : 4 acquisitions on 12 or 6 section planes

Study groups in NCT01737606
Study groupRoleWhat they receive
echographyExperimentalFast Cerebral Pulsatility Imaging
Receives: Device: Fast Cerebral Pulsatility Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1 : to validate the technical procedure, we will appreciate several parameters

    • Time of implementation of procedure
    • Qualitative identification of anatomical landmarks of positioning in space of the US probe using neuro-navigation system; if available quantitative measure: x,y,z or distance to a region of interest(ROI)
    • Perfusion values: Cerebral Blood Flow of Willis' Circle in MRI
    • Signal to noise ratio
    • Amplitude (max displacement value), location (x,y,z of location of this max or distance to a ROI) of FCPI
    • Bandwidth of metrology of FCPI
    • Possibility to indentify the propagation phenomenon underlying to displacements (speed and attenuation of the shear wave)

    Measured: up to 8 days after consent

  2. Phase 2 : the primary outcome measures will be the maximum amplitude and the average amplitude of cerebral movements

    We hypothesize that the variables describing the FCPI will decrease with age. The primary outcome measures will be the maximum amplitude and the average amplitude of cerebral movements measured in µm in planes chosen previously (for example plan of Circle of Willis and a plane including the dorsolateral area of prefrontal cortex).

    Measured: up to 8 days after consent

Secondary outcomes (4)

  1. Phase 2 : Maps of cerebral displacementand tissular perfusion maps

    Maps of cerebral displacement obtained by ultrasounds (amplitudes in µm and location in mm) and tissular perfusion maps obtained by Arterial Spin Labelling (Cerebral Blood Flow in µL.g-1.mn-1)

    Measured: up to 8 days after consent

  2. Phase 2 : Measures of FCPI on the regions of interest and cognitive tests

    Measures of FCPI on the regions of interest: amplitude (maximum displacement values, µm) and location x, y, z, of the location of this maximum in mm, or distance to a region of interest) on the hand and cognitive tests on the other hand expressed with a numerical score for each test.

    Measured: up to 8 days after consent

  3. Phase 2 : Measures of FCPI on the regions of interestand measures of PE EEG

    Measures of FCPI on the regions of interest: amplitude (maximum displacement values, µm) and location x, y, z, of the location of this maximum in mm, or distance to a region of interest) on the hand and measures of PE EEG on the other hand expressed in terms of amplitude (µV), latency (ms), duration (ms)

    Measured: up to 8 days after consent

  4. Phase 2 : The signal to noise ratio

    The signal to noise ratio of maps speed (m/s) and attenuation α (cm-1) of the shear wave obtained by mathematical processing of displacement maps

    Measured: up to 8 days after consent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJun 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01737606
Sponsor's protocol ID
PHAO 2012 - FP / COSTUM
Acronym
COSTUM
Status last verified
Dec 2025
First submitted
19 Nov 2012
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • Angel L, Bouazzaoui B, Isingrini M, Fay S, Taconnat L, Vanneste S, Ledoux M, Gissot V, Hommet C, Andersson F, Barantin L, Cottier JP, Pasco J, Desmidt T, Patat F, Camus V, Remenieras JP. Brain tissue pulsatility mediates cognitive and electrophysiological changes in normal aging: Evidence from ultrasound tissue pulsatility imaging (TPI). Brain Cogn. 2018 Jun;123:74-80. doi: 10.1016/j.bandc.2018.02.001. Epub 2018 Mar 13.

    PubMed 29544170

Questions about this trial

What is this clinical trial studying?

A study testing Fast Cerebral Pulsatility Imaging in people with Aging and Cerebral Pulsatility, 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 23 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 : to validate the technical procedure, we will appreciate several parameters (time frame: up to 8 days after consent). The study lists 2 primary outcomes in all. 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 NCT01737606, which also lists 1 linked publication.

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 23 Dec 2025.

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