Clinical trial NCT01737606: Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging
Official title: Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cerebral Pulsatility
Keywords: Cerebral pulsatility
Fast Cerebral Pulsatility Imaging or FCPI
MRI
Arteriel Spin Labelling
Cognitive tasks
Aging
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

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 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

Primary outcomes:
measure: Phase 1 : to validate the technical procedure, we will appreciate several parameters
timeFrame: up to 8 days after consent
measure: Phase 2 : the primary outcome measures will be the maximum amplitude and the average amplitude of cerebral movements
timeFrame: up to 8 days after consent
Secondary outcomes:
measure: Phase 2 : Maps of cerebral displacementand tissular perfusion maps
timeFrame: up to 8 days after consent
measure: Phase 2 : Measures of FCPI on the regions of interest and cognitive tests
timeFrame: up to 8 days after consent
measure: Phase 2 : Measures of FCPI on the regions of interestand measures of PE EEG
timeFrame: up to 8 days after consent
measure: Phase 2 : The signal to noise ratio
timeFrame: up to 8 days after consent
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Tours
name: Frédéric PATAT, MD
role: PRINCIPAL_INVESTIGATOR
References: