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

NCT04499092 | Completed

• 1 other identifier: 607rev1
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acquired Brain Injury; Development, Child

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition -CPT-3

  Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition-CPT-3 measure sustained attention. K-CPT-2 is used with children aged up to 7:11 years, while CPT-3 is adopted with children aged 8:0-17:11 years. Scores will be expressed as T scores (M=50, SD=10). Higher scores indicate worse outcomes.

  before and immediately after the intervention

Secondary Outcomes (16)

• BVN visual selective attention

  before and immediately after the intervention

• Benton Judgment of Line Orientation Test

  before and immediately after the intervention

• BVN Phonemic fluency

  before and immediately after the intervention

• ToL Total moves

  before and immediately after the intervention

• NEPSY-II Theory of Mind subscale

  before and immediately after the intervention

Study Arms (2)

Personalized neuropsychological treatment (CORE-ABI)

ACTIVE COMPARATOR

Each patient will receive greater stimulation of the most deficient cognitive function(s), while at the same time being trained on all the other functions.

Other: Personalized Neuropsychological treatment (CORE-ABI)

Sequential neuropsychological treatment (SET-ABI)

EXPERIMENTAL

Each patient will receive a fixed-dose stimulation of each cognitive function following a sequential order.

Other: Sequential Neuropsychological treatment (SET-ABI)

Interventions

Personalized Neuropsychological treatment (CORE-ABI) OTHER

Personalized neuropsychological treatment. In the CORE-ABI intervention, the stimulation of cognitive functions will be provided based on a weekly evaluation of child's cognitive profile by a qualified neuropsychologist. Each session will have a duration of 45 min. While the first 30 minutes will be devoted to the stimulation of the most impaired cognitive function(s), the remaining 15 minutes will ensure the stimulation of the other cognitive subdomains. Domains addressed by the intervention will be the following: selective attention, sustained and divided attention, inhibition and shifting, visual-perceptual abilities, visual-spatial abilities, visual-constructional abilities, short-term memory, long-term memory, working-memory, categorization/reasoning/abstraction, problem-solving/planning and socio-emotional skills.

Personalized neuropsychological treatment (CORE-ABI)

Sequential Neuropsychological treatment (SET-ABI) OTHER

Sequential Neuropsychological Treatment. In the SET-ABI intervention, the stimulation of cognitive functions will be provided following a sequential order, identical for each child and for each session in each setting (neuropsychological treatment, speech therapy treatment and psychoeducational treatment). Each session will have a duration of 45 min. Specifically, the first three weeks (weeks 1-3) of treatment will target attention; in weeks 4-6, the domain of visual-spatial and visual-constructional abilities will be addressed; in weeks 7-9, memory will be the target domain; in weeks 10-12, executive functions and socio-emotional skills will be addressed.

Sequential neuropsychological treatment (SET-ABI)

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged between 0 and 5 years
• no suspicion of the presence of a neurodevelopmental disorder
• For the preliminary validation of the Coma Recovery Scale in clinical subjects:
• age between 0 and 10 years at the moment of the pathological event
• LOCFAS score \<5
• a documented diagnosis of moderate-to-severe acquired brain injury of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS\<12)
• For the evaluation and comparison of the efficacy of two multidomain neuropsychological treatments (CORE-ABI vs SET-ABI) in children emerged from a disorder of consciousness:
• age between 5:0 and 17:11 years at the moment of the ABI
• LOCFAS score\>5
• time between ABI and assessment \<3 months
• GCS \<12 in the acute phase
• negative anamnesis for other developmental disorders before the ABI

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, Italy, 23842, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Caregivers of participants are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will have the following steps: * Adaptation/preliminary validation of the CRS-R for the Italian context (typically developing children, healthy volunteers) (N=64) * Preliminary validation of the CRS-R in a sample of Italian patients with disorder of consciousness (N=80) * Evaluation and comparison of the efficacy of two multidomain neuropsychological treatments (CORE-ABI vs SET-ABI) in children emerged from a disorder of consciousness (N=40; sample size determined through power-analysis)

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: August 5, 2020
• Study Start: October 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)