Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging (COSTUM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01737606
First received: November 19, 2012
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Aging
Cerebral Pulsatility
Device: Fast Cerebral Pulsatility Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Phase 1 : to validate the technical procedure, we will appreciate several parameters [ Time Frame: up to 8 days after consent ] [ Designated as safety issue: No ]
    • 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)

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Phase 2 : Maps of cerebral displacementand tissular perfusion maps [ Time Frame: up to 8 days after consent ] [ Designated as safety issue: No ]
    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)

  • Phase 2 : Measures of FCPI on the regions of interest and cognitive tests [ Time Frame: up to 8 days after consent ] [ Designated as safety issue: No ]
    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.

  • Phase 2 : Measures of FCPI on the regions of interestand measures of PE EEG [ Time Frame: up to 8 days after consent ] [ Designated as safety issue: No ]
    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)

  • Phase 2 : The signal to noise ratio [ Time Frame: up to 8 days after consent ] [ Designated as safety issue: No ]
    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


Enrollment: 53
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: echography
Fast Cerebral Pulsatility Imaging
Device: Fast Cerebral Pulsatility Imaging
Cerebral ultrasonic exploration using with neuro-navigation system : 4 acquisitions on 12 or 6 section planes
Other Name: FCPI

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01737606

Locations
France
University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Frédéric PATAT, MD University Hospital of Tours
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01737606     History of Changes
Other Study ID Numbers: PHAO 2012 - FP / COSTUM
Study First Received: November 19, 2012
Last Updated: September 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Cerebral pulsatility
Fast Cerebral Pulsatility Imaging or FCPI
MRI
Arteriel Spin Labelling
Cognitive tasks
Aging

ClinicalTrials.gov processed this record on September 30, 2014