NCT06826287 7T Anatomo-functional Characterization of Structures in the Action Observation Network
| NCT ID | NCT06826287 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Fondazione Stella Maris |
| Condition | Brain Function |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2025-08-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-12-02 with a primary completion date of 2025-08-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
For CP patients Inclusion Criteria: * 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; 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; 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;
Contact & Investigator
Laura Biagi, PhD
PRINCIPAL INVESTIGATOR
IRCCS Stella Maris
Frequently Asked Questions
Who can join the NCT06826287 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 40 Years, studying Brain Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06826287 currently recruiting?
Yes, NCT06826287 is actively recruiting participants. Contact the research team at laura.biagi@fsm.unipi.it for enrollment information.
Where is the NCT06826287 trial being conducted?
This trial is being conducted at Calambrone, Italy, Calambrone, Italy.
Who is sponsoring the NCT06826287 clinical trial?
NCT06826287 is sponsored by IRCCS Fondazione Stella Maris. The principal investigator is Laura Biagi, PhD at IRCCS Stella Maris. The trial plans to enroll 40 participants.