NCT04499092: COREABI

COgnitive REhabilitation in Pediatric Patients with ABI, from Vegetative State to Functional Recovery

Completed NA Last updated 13 December 2024

What this trial tests

NA trial testing Personalized Neuropsychological treatment (CORE-ABI) in Acquired Brain Injury in 184 participants. Completed in 31 December 2023.

Timeline

1 October 2019

Primary endpoint
28 February 2022

31 December 2023

Quick facts

Lead sponsor	IRCCS Eugenio Medea
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	184
Start date	1 October 2019
Primary completion	28 February 2022
Estimated completion	31 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• Personalized Neuropsychological treatment (CORE-ABI)
• Sequential Neuropsychological treatment (SET-ABI)

Conditions studied

• Acquired Brain Injury — all drugs for Acquired Brain Injury →
• Development, Child — all drugs for Development, Child →

Sponsor

IRCCS Eugenio Medea — full company profile →

Who can join

Adults 3 Months to 17, any sex, with Acquired Brain Injury or Development, Child. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acquired brain injuries (ABI) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progress of the last decade has increased the percentages of survivals, also in patients with the most severe clinical pictures. On the other hand, a brain injury reported in the first years of life presents with a more dramatic impact on cognitive and neurological development of patients and it may significantly interfere with adjustment, vocational perspectives and quality of life. Recent studies suggest that a brain damage at an early stage of development is related to more persistent sequelae in comparison with a comparable lesion reported by an adult patient, because of the neurological immaturity of the central nervous system at the moment of the insult. Furthermore, in most cases, a brain injury is related not only to motor and sensory deficits but also to significant behavioral and cognitive problems, that may occur immediately after the acute phase and persist or worsen over the years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuropsychological assessment through Coma Recovery Scale-Revised and Coma/Near Coma Scale in a sample of pediatric patients with disorder of consciousness.
   Frigerio S, Molteni E, Colombo K, Pastore V, et al · · 2023 · cited 12× · PMID 36335241 · DOI 10.1007/s00415-022-11456-6
2. Randomized clinical trial on the effects of early cognitive interventions for children with acquired brain injury.
   Corti C, Frigerio S, Recla M, Galbiati S, et al · · 2025 · PMID 40596349 · DOI 10.1038/s41598-025-06793-1