Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty (NeC)

August 18, 2025 updated by: PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00168
        • UOC Neuroriabilitazione ad alta intensità, Fondazione Policlinico Universitario "A. Gemelli"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult male and female patients with severe acquired brain injury who underwent craniotomy and subsequent opercular reapposition who met the inclusion criteria and did not meet any exclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary objective
The primary objective of the study is to analyze the neuropsychological profile of a sample of patients with severe acquired brain injury, who underwent craniotomy and subsequent opercular reapposition surgery 30 days after surgery.
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
Secondary objective
Evaluate the relationship between neuropsychological aspects and neurosurgical intervention of opercular re-opposition 7 days after surgery and any differences between 7 and 30 days; Analyze motor performance; Analyze cerebral metabolism of the patient sample. Analyze motor performance of the patient sample:
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological profile
Time Frame: 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
At baseline (T0) and 30 days after surgery (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the various aspects
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Actual)

May 19, 2025

Study Completion (Estimated)

May 19, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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