跳至主要内容
临床试验/NCT06826287
NCT06826287招募中不适用

More Than Cerebral Cortex: 7T Anatomo-functional Characterization of Cortical, Subcortical, and Cerebellar Structures Involved in the Network of Action Observation

IRCCS Fondazione Stella Maris2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
7T activation maps of the AON

研究概览

简要总结

The goal of this study is to explore the anatomical-functional characteristics of the AON circuit (with particular interest for subcortical areas and the cerebellum), and the cortico-subcortical connectivity of the nodes of the AON circuit, using an ultra-high field (7T), high spatial resolution Magnetic Resonance Imaging protocol.

The main questions it aims to answer are:

  • Can we demonstrate the involvement of subcortical areas and cerebellum in the AON circuit in each single-subject?
  • Can we obtain similar results in a small group of patients with Cerebral Palsy (CP), in order to demonstrate the feasibility of this approach for the study of the mechanisms of AON reorganization, after early brain damage?
  • Are different patterns of functional activation correlated to different clinical characteristics of CP patients?

Participants will perform a 7 Tesla MRI scan, with a functional and anatomical dedicated protocol and will have a comprehensive clinical assessment before the MRI exam.

详细描述

In healthy humans, brain functional representation of actions, either executed or observed, relies on the human action observation network (AON). Several studies demonstrated that AON activation is crucial for action understanding and for subserving imitation by observation of new motor skills. The demonstration of the activation of this circuit in patients with motor disorders have opened the way to new rehabilitation protocols based on the observation of meaningful actions followed by their execution (Observation to Imitate), often referred as Action Observation Therapy (AOT). In the last decade, AOT was widely used in adult stroke patients as well as in children with cerebral palsy (CP). Overall, these studies demonstrate a significant motor improvement after therapy, that is maintained at follow-up.

Functional Magnetic Resonance Imaging (fMRI) studies on the effects of AOT found a positive correlation between the functional improvements of manual abilities of these patients and the enlargement of movement-related brain regions, suggesting that AOT can promote the activation of mechanisms of brain plasticity and functional reorganization of the cortical areas responsible for movements. Recently, fMRI studies have demonstrated that also other brain regions, such as the cerebellum, the thalamus and the basal ganglia, belong to the AON.

Despite numerous studies on AON, the fine-grained details of this complex network, especially at subcortical level, and the reciprocal interactions between different brain regions are largely unknown. Moreover, no studies are available at submillimeter level concerning the involvement of subcortical structures. Compared with lower magnetic field systems, Ultra-High Field Magnetic Resonance (UHF-MR) permits a remarkable gain in terms of signal to noise ratio (SNR). This significant increase in SNR produces a great improvement of all imaging parameters, and can be exploited increasing spatial and/or temporal resolution. Moreover, at 7T, we assist also to an empowered sensitivity of the signal to modifications of the composition of tissue that can be translated in new or improved contrasts, such as susceptibility-weighted imaging.

fMRI technique is an advanced MR method that benefits from the use of UHF thanks to the positive combination of increased SNR and increased sensitivity to the effect generating the contrast (BOLD effect).

It has been demonstrated that an increase in the spatial resolution of UHF fMRI allows to describe the functional architecture of the cerebral cortex at mesoscopic (sub-millimeter) scale, hence revealing cortical columns-laminar fMRI profiles, and to segment subcortical structures, to explore their functional selectivity to external stimuli and topographic organization, and to study the cortex. Moreover, the increase in the sensitivity of fMRI at 7T allows to obtain statistically significant functional maps of brain activation not only in groups of subjects but also in individual subjects and individual events, opening new perspectives in the use of fMRI for clinical purposes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
11 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with pre-, peri- or post-natal brain injury, documented by a previous MRI examination of the brain;
  • Intellectual development within the norm or within the mild deficit area, to guarantee understanding and cooperation in the 7T fMRI study;
  • Understanding of the Italian language;

排除标准

  • Contraindications to performing the 7T fMRI exam;
  • Neuropsychiatric comorbidity that precludes collaboration in the 7T fMRI study;
  • Lack of capacity to understand and to will;
  • Pregnancy;
  • For Healthy Controls
  • Inclusion Criteria:
  • Absence of known neurological and psychiatric pathologies;
  • Understanding of the Italian language;
  • Exclusion Criteria:
  • Contraindications to performing the 7T fMRI exam;
  • Neuropsychiatric comorbidity that precludes collaboration in the 7T fMRI study;
  • Lack of capacity to understand and to will;
  • Pregnancy;

结局指标

主要结局

7T activation maps of the AON

时间窗: Day 0

volume (in cubic millimeters), coordinates (in millimeters), and percentage of signal change of the cortical, subcortical and cerebellar areas elicited by the observation of goal-directed actions

7T connectivity maps of the AON

时间窗: Day 0

correlation between each pair of the cortical, subcortical and cerebellar areas elicited by the observation of goal-directed actions

次要结局

  • reproducibility(Day 0)
  • clinical correlation(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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