Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

NCT ID: NCT01737606

Last Updated: 2013-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Aging Cerebral Pulsatility

Keywords

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Cerebral pulsatility Fast Cerebral Pulsatility Imaging or FCPI MRI Arteriel Spin Labelling Cognitive tasks Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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echography

Fast Cerebral Pulsatility Imaging

Group Type EXPERIMENTAL

Fast Cerebral Pulsatility Imaging

Intervention Type DEVICE

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

Interventions

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Fast Cerebral Pulsatility Imaging

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

Intervention Type DEVICE

Other Intervention Names

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FCPI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric PATAT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Tours

Locations

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University Hospital of Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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PHAO 2012 - FP / COSTUM

Identifier Type: -

Identifier Source: org_study_id