Status:
ACTIVE_NOT_RECRUITING
Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Brain Injury
Neuropsychological Deficits
Eligibility:
All Genders
18-90 years
Brief Summary
Cranioplasty is the main reconstructive neurosurgical procedure, performed in approximately 80% of patients who have previously undergone demolitive surgeries in an emergency setting, particularly in ...
Eligibility Criteria
Inclusion
- Male or female patient aged 18 to 79 years;
- Patient with severe acquired brain injury, undergoing craniotomy and subsequent percolate repositioning;
- Patient without cognitive disorders before GCA;
- Patient with cognitive and/or psychological disorders post GCA;
- Patient, caregiver or legal guardian, has voluntarily signed the informed consent, privacy form, approved by the Ethics Committee, before performing any procedure of the study
Exclusion
- Age \<18 or over 80;
- An MMSE score less than 8;
- Language barrier;
- Education level less than 8 years of age (lower secondary school diploma);
- Medical conditions such as severe hearing loss or vision loss that in the opinion of the physician could preclude data collection;
- History of psychiatric disorders according to D5M V or ICD-10 criteria, for which, in the opinion of the physician, the patient is not suitable for enrollment;
- Onset of acute pathologies close to the post-operative period and related to the surgery (1-10 days), such as: hydrocephalus, brain infections, epileptogenic picture.
- Ongoing acute pathologies, liver, kidney or heart failure.
- Patient, caregiver or legal guardian, refuse to sign the informed consent, privacy form, approved by the Ethics Committee, before performing any study procedure
Key Trial Info
Start Date :
March 18 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 19 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06895109
Start Date
March 18 2025
End Date
May 19 2026
Last Update
August 19 2025
Active Locations (1)
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1
UOC Neuroriabilitazione ad alta intensità, Fondazione Policlinico Universitario "A. Gemelli"
Roma, RM, Italy, 00168