COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery (COREABI)

COgnitive REhabilitative Treatments in Pediatric Patients With Severe Acquired Brain Injury From Vegetative State to Functional Recovery

Acquired brain lesions (GCLA) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progresses of the last decade in the medical field have increased the percentages of survival, also in the most severe clinical pictures. On the other hand, a brain lesion reported in the first years of life presents with a more dramatic impact on the cognitive and neurological development of the patients and it can significantly interfere with the same quality of their life. Recent studies suggest that a brain damage in this stage of the life is related to more persistent sequelae in comparison of the same lesion reported by an adult patient, because of the neurological immaturity at the moment of the insult. Furthermore, in most cases, the brain lesion is related not only to motor and sensorial deficits but also to very important behavioral and cognitive problems, that can arise immediately after the acute phase, or also several years after the pathological event.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury; Development, Child
• Intervention / Treatment: Behavioral: Neuropsychological treatment

Detailed Description

The aims of the present study are:

1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale (CRS-R) for the pediatric age, with specific differentiation and taking into account the age of the patients and the specific learning that characterize each developmental stage;
2. As regards the patients with an adequate cognitive profile, to compare the effectiveness of a traditional multifunction neuropsychological treatment (cognitive functions are stimulated at the same time) vs a sequential treatment (cognitive functions are stimulated step by step).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentina Pastore, PhD; Phone Number: +39-031-877111; Email: valentina.pastore@lanostrafamiglia.it
• Study Contact Backup: Name: Sandra Strazzer, PhD; Phone Number: +39-031-877854; Email: sandra.strazzer@lanostrafamiglia.it

Study Locations

• Italy
  • Bosisio Parini, Italy, 23842
    • IRCCS Eugenio Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

For the adaptation of the CRS-R:

Healthy subjects:

• children aged between 0 and 5 years (N=48);
• normal development.

Clinical subjects:

• Age between 0 and 10 at the moment of the pathological event;
• LOCFAS score <5;
• A documented diagnosis of severe acquired brain lesion of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS<12);
• Brain lesion reported within one year from the day of the inclusion in the study.

For the comparison between multifunction treatment vs sequential treatment:

• Age between 5 and 18 years at the moment of the pathological event;
• LOCFAS score>5
• time between the GCLA and the assessment < 3 months
• Documented GCLA
• GCS <12 in the acute phase
• Negative anamnesis for other developmental disorders before the GCLA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multifunction treatment; Patients that will receive a simulataneous multifunction treatment	Behavioral: Neuropsychological treatment; Neuropsychological treatment
Experimental: Sequential treatment; Patients will receive a sequential function by function treatment	Behavioral: Neuropsychological treatment; Neuropsychological treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multifunction treatment (Attention)	Continuous Performance Test 2nd Edition (CPT, Conners, 2000): is a neuropsychological test that measures a person's sustained and selective attention. Sustained attention is the ability to maintain a consistent focus on some continuous activity or stimuli, and is associated with impulsivity. Selective attention is the ability to focus on relevant stimuli and ignore competing stimuli. This skill is associated with distractibility	immediately after the intervention
Multifunction treatment (Attention)	Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005) is a test battery for the neuropsychological evaluation of the main cognitive functions (language, visual perception, memory, neuro-motor associations, attention, higher executive functions, reading, writing and calculation) in children from 5 to 11 years old. It helps analyze the development of cognitive functions and the detection of developmental or acquired cognitive pathologies.	immediately after the intervention
Multifunction treatment (Memory)	Rey-Osterrieth complex figure test (ROCF, Rey, 1941) is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall).	immediately after intervention
Multifunction treatment (Memory)	Corsi Test (De Renzi & Nicheli, 1975) is a neuropsychological assessment that measures the visual spatial span, that is the quantity of visual and spatial information that it is possible to maintain in the Short-Term Memory	immediately after intervention
Multifunction treatment (Memory)	Digit Sequencing or Digit Span test (Blackburn, 1957) is one of the main tools developed to measure one's verbal working memory. The test was originally designed to test working memory and attention, as part of the Wechsler Intelligence Scale. Usually, the examiner reads a list of numbers, and the participant repeats them until an incorrect answer is given.	immediately after intervention
Multifunction treatment (Memory)	Developmental Age Neuropsychological Evaluation Battery (DANEB, Gugliotta et al. 2005): see above	immediately after intervention
Multifunction treatment (Executive Functions)	Tower of London test (Shallice, 1982) is a test used in applied clinical neuropsychology for the assessment of executive functioning specifically to detect deficits in planning.	immediately after intervention
Multifunction treatment (Executive Functions)	Wisconsin Card Sorting Test (WCST, Kongs, Thompson, Iverson, & Heaton, 2000) is a neuropsychological test that is frequently used to measure such higher-level cognitive processes as attention, perseverance, WM, abstract thinking, and set shifting.	immediately after intervention
Multifunction treatment (Executive Functions)	Behavior Rating Inventory of Executive Function (BRIEF; Gioia et al. 2000) is an assessment of executive function behaviors at home and at school for children and adolescents ages 5-18.	immediately after intervention
Multifunction treatment (Executive Functions)	Developmental NEuroPSYchological Assessment (NEPSY, Korkman, Kirk & Kemp, 1998) is a series of neuropsychological tests that are used in various combinations to assess neuropsychological development in children ages 3-16 years in six functional domains.	immediately after intervention
Multifunction treatment (Visual perceptual functions)	Test of Visual Perceptual Skills (TVPS-4, Martin, 2008) is the latest update of the standard comprehensive assessment of visual analysis and processing skills. The TVPS-4 remains an easy-to-use assessment for determining visual-perceptual strengths and weaknesses.	immediately after intervention
Multifunction treatment (Visual perceptual functions)	Benton Visual Retention Test (Benton test or BVRT, Benton, 1946) is an individually administered test for people aged from eight years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory.	immediately after intervention
Multifunction treatment (Visual perceptual functions)	Rey-Osterrieth complex figure test (ROCF, Rey, 1941): see above	immediately after intervention

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Unconsciousness; Consciousness Disorders; Brain Injuries; Persistent Vegetative State
• Other Study ID Numbers: 607rev1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No