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Completed

NCT Number: NCT01737606

Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

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

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Key information

Conditions

Aging Cerebral Pulsatility

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37044, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Fast Cerebral Pulsatility Imaging

Device

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

Other names: FCPI

Primary outcomes

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

    Time frame: up to 8 days after consent

    • 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)

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

    Time frame: up to 8 days after consent

    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).

Secondary outcomes

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

    Time frame: up to 8 days after consent

    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)

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

    Time frame: up to 8 days after consent

    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.

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

    Time frame: up to 8 days after consent

    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)

  4. Phase 2 : The signal to noise ratio

    Time frame: up to 8 days after consent

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: COSTUM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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