Exploring brain function in action observation for patients with cerebral palsy
More Than Cerebral Cortex: 7T Anatomo-functional Characterization of Cortical, Subcortical, and Cerebellar Structures Involved in THE Network of Action Observation
This study is trying to see how the brains of people with cerebral palsy work when they watch actions, using advanced MRI scans to better understand their brain connections and how it relates to their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 11 Years to 40 Years |
| Sex | All |
| Sponsor | IRCCS Fondazione Stella Maris Academic / other |
| Locations | 2 sites (Calambrone, PISA and 1 other locations) |
| Trial ID | NCT06826287 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the anatomical and functional characteristics of the action observation network (AON) in individuals with cerebral palsy using ultra-high field 7 Tesla magnetic resonance imaging (MRI). The research focuses on understanding the connectivity of subcortical areas and the cerebellum within the AON circuit and how these relate to clinical characteristics of patients. Participants will undergo a detailed clinical assessment followed by a 7T MRI scan to gather data on brain activation patterns. The study seeks to demonstrate the feasibility of this approach for studying brain reorganization mechanisms after early brain damage.
Who should consider this trial
Good fit: Ideal candidates include patients with cerebral palsy who have documented brain injuries and can understand Italian.
Not a fit: Patients with severe neuropsychiatric comorbidities or those unable to cooperate during the MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of brain plasticity in cerebral palsy, potentially leading to improved rehabilitation strategies.
How similar studies have performed: Previous studies have shown success in using action observation therapy in similar patient populations, indicating potential for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Calambrone, PISA and 1 other locations
- Fondazione IMAGO7 — Calambrone, Pisa, Italy (Active_not_recruiting)
- IRCCS Fondazione Stella Maris — Calambrone, Pisa, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Biagi, PhD — IRCCS Stella Maris
- Study coordinator: Laura Biagi, PhD
- Email: laura.biagi@fsm.unipi.it
- Phone: +39050886175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.