Acquired Brain InjuryCOREABINCT04499092
COgnitive REhabilitation in Pediatric Patients with ABI, from Vegetative State to Functional Recovery
A study testing Personalized Neuropsychological treatment (CORE-ABI) and Sequential Neuropsychological treatment (SET-ABI) in people with Acquired Brain Injury and Development, Child, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Development, Child
- What is being tested?
- Personalized Neuropsychological treatment (CORE-ABI) and Sequential Neuropsychological treatment (SET-ABI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 13Show fewer
- a brain lesion reported within one year from study inclusion
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COgnitive REhabilitation Treatments in Pediatric Patients with Acquired Brain Injury. from Vegetative State to Functional Recovery.
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.
Read the detailed description
The aims of the present study are:
- To contribute to the adaptation of the Italian version of the Coma Recovery Scale for pediatrics, investigating behavioral responses of children across different age and developmental levels. Typically developing children and children with disorder of cosciousness due to ABI will be included;
- For patients with an adequate cognitive profile, to compare the efficacy of two multidomain neuropsychological interventions: a personalized neuropsychological treatment and a sequential neuropsychological treatment. In the personalized neuropsychological treatment 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; in the sequential neuropsychological treatment, a fixed-dose stimulation of each cognitive function following a sequential order will be provided.
- Conditions
- Acquired Brain Injury, Development, Child
- Being tested
- Personalized Neuropsychological treatment (CORE-ABI), Sequential Neuropsychological treatment (SET-ABI)
- Keywords
- Rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sequential Neuropsychological treatment (SET-ABI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and immediately after the intervention
Secondary outcomes (16)
BVN visual selective attention
The visual selective attention task (BVN visual selective attention) of the Italian battery 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years; the same task included in the Italian battery 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' [Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
Benton Judgment of Line Orientation Test
The Benton Judgment of Line Orientation Test will be used to test visual-spatial orientation. The test targets subjects from 7:0 years onwards. Scores will be expressed as z-scores (M=0; SD=1), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
BVN Phonemic fluency
The phonemic fluency task (BVN phonemic fluency) included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 and the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza' [Battery of neuropsychological evaluation for adolescence-BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores. (M=0; SD=1), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
ToL Total moves
The Tower of London (ToL) will be used to assess planning and related problem-solving abilities. Total moves score will be used to evaluate the accuracy of planning. Scores will be expressed as Standard scores (M=100; SD=15) with higher scores indicating better outcomes. The administration sheet and normative data are available for children aged 7:0-15:11 years and adolescents and adults aged 16:0 years or older; thus children of this study aged less than 7:0 years will be not administered this test.
Measured: before and immediately after the intervention
NEPSY-II Theory of Mind subscale
The 'Theory of mind' subscale of the Italian version of the battery -A Developmental NEuroPSYchological Assessment-II (NEPSY-II) will be administered. The Theory of Mind subscale-part A assesses the understanding of mental functions and other people's perspectives, with raw scores ranging from 0 to 17; the Theory of Mind subscale-part B examines the ability to match basic emotions to specific situations. Scores will be expressed as scaled scores (M=10, SD=3), ranging from 1 to 19. Higher scores indicated better outcomes. As NEPSY-II was developed and validated for children aged 3:0-16:11 years, scores of adolescents aged 17:0-17:11 years will be calculated by considering norms for adolescents aged 15:0-16:11 years.
Measured: before and immediately after the intervention
BVN Immediate word list recall task
The BVN immediate word list recall task will be used to assess short-term verbal memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11-' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery for neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
MCST/WCST Errors
Cognitive flexibility will be assessed by using the computerized Modified Card Sorting Test (MCST) and the computerized Wisconsin Card Sorting Test (WCST). The MCST will be used for children aged 5:0-7:11, while the WCST will be used for children aged 8:0-17:11. The number of total errors (MCST/WCST errors), which represents the sum of perseverative and non-perseverative errors, will be considered for this study. Scores will be expressed as Standard scores (M=100; SD=15), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
BVN Forward digit span
The forward digit span test will be used to assess short-term memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
BVN Corsi
The Corsi block tapping task (BVN Corsi) will be used to assess visual-spatial working-memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11; the same task included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall)
The Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall) will be used to evaluate long-term visual-spatial memory. In this task children will be required to reproduce a complicated line drawing 30 minutes after presentation. Scores will be expressed as z scores (M=0; SD=1), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy)
The Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy) will be adopted to assess visual-constructional abilities. The test targets subjects from 4:0 years onwards. Scores will be expressed as z scores (M=0; SD=1), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
NEPSY-II Affect Recognition subscale
The 'Affect recognition' subscale of the Italian version of the battery -A Developmental NEuroPSYchological Assessment-II (NEPSY-II) will be administered. This subscale assesses the ability to recognize emotions on facial expressions. Scores will be expressed as scaled scores (M=10, SD=3), ranging from 1 to 19. Higher scores indicate better outcomes. As NEPSY-II was developed and validated for children aged 3:0-16:11 years, scores of adolescents aged 17:0-17:11 years will be calculated by considering norms for adolescents aged 15:0-16:11 years.
Measured: before and immediately after the intervention
Test of Visual Perceptual Skills-3rd Edition -TVPS-3-
The Italian version of the Test of Visual Perceptual Skills-3rd Edition -TVPS-3- will be used to assess visual information processing. The test targets subjects from 4:0 years through 18:11. Scores will be expressed as Standard scores (M=100; SD=15), with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
ToL Initiation Time
The Tower of London (ToL) will be used to assess planning and related problem-solving abilities. Total Initiation time score will be used to evaluate the time used to planning for problem-solving. Scores will be expressed as Standard scores (M=100; SD=15) with higher scores indicating better outcomes. The administration sheet and normative data are available for children aged 7:0-15:11 years and adolescents and adults aged 16:0 years or older; thus children of this study aged less than 7:0 years will be not administered this test.
Measured: before and immediately after the intervention
BVN Backward digit span
The Backward digit span test will be used to assess verbal working-memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery of neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Patients will be required to repeat a sequence of numbers presented by the examiner in a reverse order. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
BVN Delayed word list recall task
The BVN delayed word list recall task will be used to assess long-term verbal memory. The task included in the Italian 'Batteria di valutazione neuropsicologica per l'età evolutiva -BVN 5-11-' [Battery for neuropsychological evaluation for developmental age -BVN 5-11] will be used for children aged 5:0-11:11 years, while the one included in the Italian 'Batteria di Valutazione Neuropsicologica per l'adolescenza -BVN 12-18' ['Battery for neuropsychological evaluation for adolescence -BVN 12-18] will be used for children aged 12:0-17:11 years. Scores will be expressed as z-scores (M=0; SD=1) with higher scores indicating better outcomes.
Measured: before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Oct 2019
- Primary completion28 Feb 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499092
- Sponsor's protocol ID
- 607rev1
- Acronym
- COREABI
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COgnitive REhabilitation Treatments in Pediatric Patients with Acquired Brain Injury. from Vegetative State to Functional Recovery.
- ClinicalTrials.gov ID
- NCT04499092
- Acronym / sponsor ID
- COREABI / 607rev1
- Conditions
- Acquired Brain Injury, Development, Child
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aims of the present study are:
- To contribute to the adaptation of the Italian version of the Coma Recovery Scale for pediatrics, investigating behavioral responses of children across different age and developmental levels. Typically developing children and children with disorder of cosciousness due to ABI will be included;
- For patients with an adequate cognitive profile, to compare the efficacy of two multidomain neuropsychological interventions: a personalized neuropsychological treatment and a sequential neuropsychological treatment. In the personalized neuropsychological treatment 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; in the sequential neuropsychological treatment, a fixed-dose stimulation of each cognitive function following a sequential order will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Personalized neuropsychological treatment (CORE-ABI) | Active comparator | Other: Personalized Neuropsychological treatment (CORE-ABI)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. |
| Sequential neuropsychological treatment (SET-ABI) | Experimental | Other: Sequential Neuropsychological treatment (SET-ABI)Each patient will receive a fixed-dose stimulation of each cognitive function following a sequential order. |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Neuropsychological treatment (CORE-ABI)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. | Other | Personalized neuropsychological treatment (CORE-ABI) |
| Sequential Neuropsychological treatment (SET-ABI)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. | Other | Sequential neuropsychological treatment (SET-ABI) |
Primary outcome
Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition -CPT-3
Time frame: before and immediately after the intervention
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.
16 secondary outcomes
BVN visual selective attention
Time frame: before and immediately after the intervention
Benton Judgment of Line Orientation Test
Time frame: before and immediately after the intervention
BVN Phonemic fluency
Time frame: before and immediately after the intervention
ToL Total moves
Time frame: before and immediately after the intervention
NEPSY-II Theory of Mind subscale
Time frame: before and immediately after the intervention
BVN Immediate word list recall task
Time frame: before and immediately after the intervention
MCST/WCST Errors
Time frame: before and immediately after the intervention
BVN Forward digit span
Time frame: before and immediately after the intervention
BVN Corsi
Time frame: before and immediately after the intervention
Rey-Osterrieth Complex Figure Test-recall task (ROCF-recall)
Time frame: before and immediately after the intervention
Rey-Osterrieth Complex Figure Test -copy task (ROCF-copy)
Time frame: before and immediately after the intervention
NEPSY-II Affect Recognition subscale
Time frame: before and immediately after the intervention
Test of Visual Perceptual Skills-3rd Edition -TVPS-3-
Time frame: before and immediately after the intervention
ToL Initiation Time
Time frame: before and immediately after the intervention
BVN Backward digit span
Time frame: before and immediately after the intervention
BVN Delayed word list recall task
Time frame: before and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Neuropsychological treatment (CORE-ABI) and Sequential Neuropsychological treatment (SET-ABI) in people with Acquired Brain Injury and Development, Child, run by IRCCS Eugenio Medea 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 13 inclusion and 0 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: finished, as of the sponsor's last update on 13 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Conners Kiddie Continuous Performance Test-2nd Edition -K-CPT-2/Continuous Performance Test-3rd Edition -CPT-3 (time frame: before and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.