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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

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

Treatments: Other: improvement of cognitive functions and psychological aspects

Study type: Observational

Funder types: Other

Identifiers

NCT06895109

6349

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Primary objective

Description:

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.

Treatment:

Other: improvement of cognitive functions and psychological aspects

Secondary objective

Description:

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:

Treatment:

Other: improvement of cognitive functions and psychological aspects