Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Phase 1 : to validate the technical procedure, we will appreciate several parameters
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
echography
Fast Cerebral Pulsatility Imaging
干预措施: Fast Cerebral Pulsatility Imaging (Device)
结局指标
主要结局
Phase 1 : to validate the technical procedure, we will appreciate several parameters
时间窗: up to 8 days after consent
* 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
时间窗: up to 8 days after consent
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).
次要结局
- Phase 2 : Maps of cerebral displacementand tissular perfusion maps(up to 8 days after consent)
- Phase 2 : Measures of FCPI on the regions of interest and cognitive tests(up to 8 days after consent)
- Phase 2 : Measures of FCPI on the regions of interestand measures of PE EEG(up to 8 days after consent)
- Phase 2 : The signal to noise ratio(up to 8 days after consent)