Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty

NCT06895109 | Active Not Recruiting

• 1 other identifier: 6349
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

brain injury; cranioplasty; cognitive deficit following brain lesions; neuropsychological deficits; craniectomy; neurosurgical procedure; neurorehabilitation; rehabilitation treatment; cognitive outcome; acquired brain injury; braininjury acute; craniocerebral injury

Outcome Measures

Primary Outcomes (1)

• Neuropsychological profile

  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 Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

improvement of cognitive functions and psychological aspects 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

Primary objective; Secondary objective

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Roma, RM, 00168, Italy

Location

Related Publications (9)

• 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.

  PMID: 39407375 BACKGROUND

• 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.

  PMID: 34830718 BACKGROUND

• 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.

  PMID: 25640571 BACKGROUND

• 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.

  PMID: 26647093 BACKGROUND

• 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.

  PMID: 30280509 BACKGROUND

• 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.

  PMID: 27499122 BACKGROUND

• 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.

  PMID: 27609482 BACKGROUND

• 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.

  PMID: 34674047 BACKGROUND

• 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.

  PMID: 30681549 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direttore dell' Unità Operativa Complessa "Neuroriabilitazione ad alta intensità"

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: March 18, 2025
• Primary Completion: May 19, 2025
• Study Completion (Estimated): May 19, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)