NCT06826287

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

January 22, 2025

Last Update Submit

February 12, 2025

Conditions

Brain FunctionCerebral Palsy

Keywords

magnetic resonance imagingultra high fieldaction observation networkcerebral palsyfunctional re-organizationneural plasticity

Outcome Measures

Primary Outcomes (2)

  • 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

    Day 0

  • 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

    Day 0

Secondary Outcomes (2)

  • reproducibility

    Day 0

  • clinical correlation

    Day 0

Study Arms (2)

Healthy Controls

Subject without any known neurological and psychiatric pathologies

Other: 7T MR exam

CP patients

Patients with pre-, peri- or post-natal brain injury, as documented in a previous brain MRI examination

Other: 7T MR examOther: clinical assessment

Interventions

7T MR examOTHER

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

CP patientsHealthy Controls
clinical assessmentOTHER

A comprehensive clinical assessment before the MRI exam.

CP patients

Eligibility Criteria

Age11 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic for CP; community sample for HC.

You may qualify if:

  • 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;

You may not qualify if:

  • 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
  • Absence of known neurological and psychiatric pathologies;
  • Understanding of the Italian language;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IMAGO7

Calambrone, PISA, 56018, Italy

ACTIVE NOT RECRUITING

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56018, Italy

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laura Biagi, PhD

    IRCCS Stella Maris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Biagi, PhD

CONTACT

+39050886175laura.biagi@fsm.unipi.it

Giuseppina Sgandurra, MD

CONTACT

+39050886336giuseppina.sgandurra@fsm.unipi.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 13, 2025

Study Start

December 2, 2024

Primary Completion

August 9, 2025

Study Completion

August 9, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

IT(2)