Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

Aging Clinical Trial

— COSTUM  

Official title:

Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737606
• Other study ID #: PHAO 2012 - FP / COSTUM
• Status: Completed
• Phase: N/A
• First received: November 19, 2012
• Last updated: September 27, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Aging
• Cerebral Pulsatility

Intervention

Device:
• Fast Cerebral Pulsatility Imaging
Cerebral ultrasonic exploration using with neuro-navigation system : 4 acquisitions on 12 or 6 section planes

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 : to validate the technical procedure, we will appreciate several parameters	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)	up to 8 days after consent	No
Primary	Phase 2 : the primary outcome measures will be the maximum amplitude and the average amplitude of cerebral movements	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).	up to 8 days after consent	No
Secondary	Phase 2 : Maps of cerebral displacementand tissular perfusion maps	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)	up to 8 days after consent	No
Secondary	Phase 2 : Measures of FCPI on the regions of interest and cognitive tests	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.	up to 8 days after consent	No
Secondary	Phase 2 : Measures of FCPI on the regions of interestand measures of PE EEG	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)	up to 8 days after consent	No
Secondary	Phase 2 : The signal to noise ratio	The signal to noise ratio of maps speed (m/s) and attenuation a (cm-1) of the shear wave obtained by mathematical processing of displacement maps	up to 8 days after consent	No