Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty

NCT ID: NCT06895109

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2026-05-19

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

improvement of cognitive functions and psychological aspects

Intervention Type: OTHER

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:

improvement of cognitive functions and psychological aspects

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

PADUA LUCA

Direttore dell' Unità Operativa Complessa "Neuroriabilitazione ad alta intensità"

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UOC Neuroriabilitazione ad alta intensità, Fondazione Policlinico Universitario "A. Gemelli"

Roma, RM, Italy

Countries

Italy

References

Sheikh MA, Ali S, Khan A. Uroflowmetry: nomograms in healthy young Pakistani men. J Pak Med Assoc. 2024 Oct;74(10):1806-1810. doi: 10.47391/JPMA.10626.

Reference Type: BACKGROUND

PMID: 39407375 (View on PubMed)

Corallo F, Lo Buono V, Calabro RS, De Cola MC. Can Cranioplasty Be Considered a Tool to Improve Cognitive Recovery Following Traumatic Brain Injury? A 5-Years Retrospective Study. J Clin Med. 2021 Nov 21;10(22):5437. doi: 10.3390/jcm10225437.

Reference Type: BACKGROUND

PMID: 34830718 (View on PubMed)

Corallo F, Calabro RS, Leo A, Bramanti P. Can cranioplasty be effective in improving cognitive and motor function in patients with chronic disorders of consciousness? A case report. Turk Neurosurg. 2015;25(1):193-6. doi: 10.5137/1019-5149.JTN.10618-14.2.

Reference Type: BACKGROUND

PMID: 25640571 (View on PubMed)

Di Stefano C, Rinaldesi ML, Quinquinio C, Ridolfi C, Vallasciani M, Sturiale C, Piperno R. Neuropsychological changes and cranioplasty: A group analysis. Brain Inj. 2016;30(2):164-71. doi: 10.3109/02699052.2015.1090013. Epub 2015 Dec 8.

Reference Type: BACKGROUND

PMID: 26647093 (View on PubMed)

De Cola MC, Corallo F, Pria D, Lo Buono V, Calabro RS. Timing for cranioplasty to improve neurological outcome: A systematic review. Brain Behav. 2018 Nov;8(11):e01106. doi: 10.1002/brb3.1106. Epub 2018 Oct 2.

Reference Type: BACKGROUND

PMID: 30280509 (View on PubMed)

Malcolm JG, Rindler RS, Chu JK, Grossberg JA, Pradilla G, Ahmad FU. Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. J Clin Neurosci. 2016 Nov;33:39-51. doi: 10.1016/j.jocn.2016.04.017. Epub 2016 Aug 4.

Reference Type: BACKGROUND

PMID: 27499122 (View on PubMed)

Corallo F, De Cola MC, Lo Buono V, Marra A, De Luca R, Trinchera A, Bramanti P, Calabro RS. Early vs late cranioplasty: what is better? Int J Neurosci. 2017 Aug;127(8):688-693. doi: 10.1080/00207454.2016.1235045. Epub 2016 Sep 28.

Reference Type: BACKGROUND

PMID: 27609482 (View on PubMed)

Ozoner B. Cranioplasty Following Severe Traumatic Brain Injury: Role in Neurorecovery. Curr Neurol Neurosci Rep. 2021 Oct 21;21(11):62. doi: 10.1007/s11910-021-01147-6.

Reference Type: BACKGROUND

PMID: 34674047 (View on PubMed)

Corallo F, De Cola MC, Lo Buono V, Cammaroto S, Marra A, Manuli A, Calabro RS. Recovery of Severe Aphasia After Cranioplasty: Considerations on a Case Study. Rehabil Nurs. 2020 Jul/Aug;45(4):238-242. doi: 10.1097/rnj.0000000000000212.

Reference Type: BACKGROUND

PMID: 30681549 (View on PubMed)

Other Identifiers

6349

Identifier Type: -

Identifier Source: org_study_id