AzTrials
AzTrials

Brain InjuryNeCNCT06895109

Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty

An observational study of Brain Injury and Neuropsychological Deficits, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
improvement of cognitive functions and psychological aspects
How many people
20 participants
Where
1 siteItaly
Study dates
18 Mar 2025to 19 May 2026
How long will I take part?
2 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Roma, RM, 00168

Other trials in Italy

About this study

Official title: 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.

Being tested
improvement of cognitive functions and psychological aspects
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
Medical subject headings
Brain Injuries, Cognitive Dysfunction, Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • improvement of cognitive functions and psychological aspectsOther

    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

Study groups in NCT06895109
Study groupRoleWhat they receive
Primary objectiveThe 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.
Receives: Other: improvement of cognitive functions and psychological aspects
Secondary objectiveEvaluate 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:
Receives: Other: improvement of cognitive functions and psychological aspects

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At baseline (T0) and 30 days after surgery (T1)

Secondary outcomes (1)

  1. Analyze the various aspects

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2025
  2. Study start18 Mar 2025
  3. Primary completion19 May 2025
  4. Study completion19 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06895109
Sponsor's protocol ID
6349
Acronym
NeC
Status last verified
Aug 2025
First submitted
19 Mar 2025
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39407375

  • 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.

    PubMed 34830718

  • 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.

    PubMed 25640571

  • 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.

    PubMed 26647093

  • 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.

    PubMed 30280509

  • 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.

    PubMed 27499122

  • 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.

    PubMed 27609482

  • 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.

    PubMed 34674047

  • 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.

    PubMed 30681549

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injury and Neuropsychological Deficits, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychological profile (time frame: At baseline (T0) and 30 days after surgery (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06895109, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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