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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Cerebral Pulsatility
Aging

Treatments

Device: Fast Cerebral Pulsatility Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01737606
PHAO 2012 - FP / COSTUM

Details and patient eligibility

About

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

Full 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

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

echography
Experimental group
Description:
Fast Cerebral Pulsatility Imaging
Treatment:
Device: Fast Cerebral Pulsatility Imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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