Clinical trial NCT06895109: Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty
Official title: Evaluation of Improvement in Cognitive Functions and Psychological Aspects in Patients With Severe Acquired Brain Injury After Cranioplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Neuropsychological profile
timeFrame: At baseline (T0) and 30 days after surgery (T1)
Secondary outcomes:
measure: Analyze the various aspects
timeFrame: 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.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: UOC Neuroriabilitazione ad alta intensità, Fondazione Policlinico Universitario "A. Gemelli"
state: RM
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.