NCT06895109

Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty

Evaluation of Improvement in Cognitive Functions and Psychological Aspects in Patients With Severe Acquired Brain Injury After Cranioplasty

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Injury
• Neuropsychological Deficits
• Cranioplasty
• Cognitive Deficit Following Brain Lesions
• Craniectomy
• Brain Injury, Acute
• Acquired Brain Injury
• Rehabilitation
• Rehabilitation Outcome
• Cognitive Disorders
• Neurorehabilitation

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2025-03-18
• Primary completion: 2025-05-19
• Completion: 2026-05-19
• First posted: 2025-03-26
• Last updated: 2025-08-19

Locations

1 site across 1 country: Italy