Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty

Active, not recruiting

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

• Registration Number: NCT06895109
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-18
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-05-19
• Study Completion: 2026-05-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Analyze the various aspects	At T0: at the time of admission (pre-surgery); At T1: approximately one week after the operculum repositioning procedure; > At T2: approximately one month after the operculum repositioning procedure.	To evaluate the relationship between neuropsychological aspects and neurosurgical intervention of opercular reopposition, to analyze motor performances, cerebral metabolism and motor performances of the patient sample.

Trial Locations

Locations (1)

UOC Neuroriabilitazione ad alta intensità, Fondazione Policlinico Universitario "A. Gemelli"; 🇮🇹 Roma, RM, Italy