Health TrialsbyHealthPanel

7T Anatomo-functional Characterization of Structures in the Action Observation Network

ConditionsBrain FunctionCerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-40
SponsorIRCCS Fondazione Stella Maris

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

primary care clinic for CP; community sample for HC.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 7T MR exam

    Other intervention

    a 7 Tesla MRI scan, with a functional and anatomical dedicated protocol

  • clinical assessment

    Other intervention

    A comprehensive clinical assessment before the MRI exam.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Healthy Controls1 intervention
Group B: CP patients2 interventions

Trial outcomes

Primary outcomes

1

7T activation maps of the AON

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

Time frame
Day 0
2

7T connectivity maps of the AON

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

Time frame
Day 0

Secondary outcomes

1

reproducibility

percentage of healthy subjects in which it is possible to identify the AON circuit

Time frame
Day 0
2

clinical correlation

correlation between characteristics of activations (described as primary outcomes) and clinical assessment

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Fondazione Stella Maris

Lead sponsor

University of Parma

Collaborator

Fondazione IMAGO7

Collaborator

Source ClinicalTrials.gov
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