Ireland
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Active, not recruiting Observational

Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty

NCT06895109 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-03-18
Last updated
2025-08-19

Condition(s) studied

Brain InjuryNeuropsychological DeficitsCranioplastyCognitive Deficit Following Brain LesionsCraniectomyBrain Injury, AcuteAcquired Brain InjuryRehabilitationRehabilitation OutcomeCognitive DisordersNeurorehabilitation

Investigational drug(s) / intervention(s)

improvement of cognitive functions and psychological aspects

improvement of cognitive functions and psychological aspects: To analyze the neuropsychological, motor and functional profile of a sample of patients with severe acquired brain injury, who underwent craniotomy and subsequent opercular reapposition surgery

Study 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 the case of decompressive craniectomy . It mainly aims to ensure the protection of brain tissue and improve the aesthetic appearance. Statistical correlation analyses between timing of cranioplasty and neurological recovery are probably in favor of early cranioplasty. Cranioplasty improves motor and cognitive rehabilitation outcomes. However, it carries an increased risk of postoperative complications, such as seizures and infections. Other studies show that cranioplasty performed 3 to 6 months after craniectomy can significantly improve motor and cognitive recovery.

The timing of the intervention plays a fundamental role in enucleating cognitive improvement. In fact, greater cognitive changes have been observed in patients who underwent cranioplasty within 6 months of the injury. Therefore, cranioplasty must be considered a key factor for neuropsychological recovery and should be performed early in order to make the most of the rehabilitation window. In the literature, there are studies that have evaluated how cranioplasty can facilitate cognitive recovery, regardless of timing. In particular, a significant cognitive recovery was observed in the period immediately following cranioplasty, while the improvement stabilizes after a certain period of time and recovery begins to slow down. In patients with severe acquired brain injury (GCA), cranioplasty seems to significantly improve neuropsychological and motor function, even after a long time from the procedure. The aim of the study is therefore to evaluate whether in patients with severe acquired brain injury who underwent cranioplasty in the neurorehabilitation setting there is an improvement in cognitive, motor functions and psychological aspects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Neuropsychological profile — At baseline (T0) and 30 days after surgery (T1)
    To analyze the neuropsychological profile of a sample of patients with severe acquired brain injury, who underwent craniotomy and subsequent opercular reapposition surgery

Trial sites (1)

FacilityCityRegionStatus
UOC Neuroriabilitazione ad alta intensità, Fondazione Policlinico Universitario "A. Gemelli" Roma RM
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06895109 on ClinicalTrials.gov ↗ ← All trials in Italy