Executive FunctionsNCT03639298
Executive Functions Rehabilitation in Premature Children
A study testing Intendu in people with Executive Functions, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial summary
in more than 60% of premature children processing speed and academic failures are observed, even in children with a normal cognitive level. The aim of the study is to use for rehabilitation an application for training functional cognitive skills (Intendu®). Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Executive Functions
- What is being tested?
- Intendu
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 11 Sep 2018to 20 Oct 2020
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born between 23-36.5 weeks of gestation
- age between 4 and 0 month -6 years and 11 months
- included in the V, Buzzi children's Hospital follow-up program
- resident no further than 20 km from the V. Buzzi Children's Hospital
- with WPPSI-III processing speed quotient of 91 or less
Who cannot join
- children affected by epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premature Children-executive Functions and Training With Cognitive Motion-based Videogames (Intendu®): a Rehabilitation Project
in more than 60% of premature children processing speed and academic failures are observed, even in children with a normal cognitive level.
The aim of the study is to use for rehabilitation an application for training functional cognitive skills (Intendu®). It is a software which is able to interact with the patient through a video monitoring feedback (Kinect®), enhancing brain plasticity of patients with brain dysfunction.
Read the detailed description
In Europe 6.2% of the births are born before 37 weeks of gestation. After a long period in Neonatal Intensive Care Units, the infants are dismissed but they continue to be examined in follow-up programs. It is known that advances in care have improved the rate of survival of premature newborns, but unfortunately they may have disabilities which can be severe (cerebral palsy) or mild. Mild disabilities (like attention deficit, hyperactivity, visual-perceptual and coordination disorders), even if mild, can have a significant impact on school achievements and social life. Follow-up program is dedicated to detect both severe and minor disabilities, trying to rehabilitate the children before they start formal education in school. It is well known that more than half of premature children can show impairment of processing speed and academic failures, even with normal cognitive level. Processing speed is the result of the action of different executive functions, especially working memory, planning, attention shift, inhibition and persistence.
There is growing interest over cognitive rehabilitation with video games. Recently an application for training functional cognitive skills (Intendu®) has been developed . It is a software which is able to interact with patients through a video monitoring feedback (Kinect®), enhancing brain plasticity of patients with brain dysfunction.
Aim of the study:
To evaluate whether an adaptive motion-interaction video game can improve processing speed and executive functions in premature children.
Methods:
35 children born prematurely (23-36.5 W) aged 4-6 year-old with reduced processing speed, will be invited to participate if they meet the inclusion criteria. They will be submitted to 4-5 weeks intensive training with Intendu®, (4-5 sessions per week, for a total of 20 sessions) lasting 15 minutes each, in the presence of a tutor (a psychologist expert in premature children). A control group of 35 children (no training) with the same characteristics (gestational age, cognitive profile, socio-economic status) will be available. Before and after the training/or no training the participants, in addition to the scheduled follow-up assessment, will be evaluated with two WPPSI-III®-Wechsler Preschool and Primary Scale of Intelligence subtests (Coding and Symbol search) and one Nepsy II® domain-A developmental Neuropsychological Assessment (attention and executive function). Teacher and parents evaluations will be also considered (school reports and Child Behavior Checklist - questionnaire)
- Conditions
- Executive Functions
- Being tested
- Intendu
- Keywords
- premature children, processing speed, executive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntenduDevice
intensive training with Motion Based Cognitive Video Games Software
| Study group | Role | What they receive |
|---|---|---|
| training | Experimental | children submitted to the Intendu training with motion based cognitive video games software Receives: Device: Intendu |
| no training | No intervention | children not submitted to the training, entering the study as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient
the achievement of at least 10 points change of WPPSI® Processing Speed Quotient (subtests: Coding and Symbol search) will be considered significant
Measured: assessment at baseline (time 0) and at the end of the training (after 4 weeks)
change in scaled scores of Nepsy II® (developmental Neuropsychological Assessment) attention and executive function domain
the achievement of at least 3 points change in scaled scores of Nepsy II® attention and executive function domain
Measured: assessment at baseline (time 0) and at the end of the training (after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start11 Sep 2018
- Primary completion19 Sep 2020
- Study completion20 Oct 2020
Why it stopped: Due to SARS-Cov-2 emergency we were unable to recruit the expected number of children. We will analyze the available data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Executive FunctionsStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vittore Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Scelsa, Vittore Buzzi Children's Hospital
- Investigators
- Barbara Scelsa, MD, Principal investigator, V. Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639298
- Sponsor's protocol ID
- BS1
- Status last verified
- Mar 2021
- First submitted
- 13 Aug 2018
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: protocol of the study and patient data
Publications
Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009 Jan;8(1):110-24. doi: 10.1016/S1474-4422(08)70294-1.
PubMed 19081519Johnson S. Cognitive and behavioural outcomes following very preterm birth. Semin Fetal Neonatal Med. 2007 Oct;12(5):363-73. doi: 10.1016/j.siny.2007.05.004. Epub 2007 Jul 10.
PubMed 17625996Dye MW, Green CS, Bavelier D. Increasing Speed of Processing With Action Video Games. Curr Dir Psychol Sci. 2009;18(6):321-326. doi: 10.1111/j.1467-8721.2009.01660.x.
PubMed 20485453
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Children-executive Functions and Training With Cognitive Motion-based Videogames (Intendu®): a Rehabilitation Project
- ClinicalTrials.gov ID
- NCT03639298
- Acronym / sponsor ID
- BS1
- Conditions
- Executive Functions
- Keywords
- premature children, processing speed, executive functions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to SARS-Cov-2 emergency we were unable to recruit the expected number of children. We will analyze the available data
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 19 Sep 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 21 Aug 2018 (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.
in more than 60% of premature children processing speed and academic failures are observed, even in children with a normal cognitive level.
The aim of the study is to use for rehabilitation an application for training functional cognitive skills (Intendu®). It is a software which is able to interact with the patient through a video monitoring feedback (Kinect®), enhancing brain plasticity of patients with brain dysfunction.
Detailed description
In Europe 6.2% of the births are born before 37 weeks of gestation. After a long period in Neonatal Intensive Care Units, the infants are dismissed but they continue to be examined in follow-up programs. It is known that advances in care have improved the rate of survival of premature newborns, but unfortunately they may have disabilities which can be severe (cerebral palsy) or mild. Mild disabilities (like attention deficit, hyperactivity, visual-perceptual and coordination disorders), even if mild, can have a significant impact on school achievements and social life. Follow-up program is dedicated to detect both severe and minor disabilities, trying to rehabilitate the children before they start formal education in school. It is well known that more than half of premature children can show impairment of processing speed and academic failures, even with normal cognitive level. Processing speed is the result of the action of different executive functions, especially working memory, planning, attention shift, inhibition and persistence.
There is growing interest over cognitive rehabilitation with video games. Recently an application for training functional cognitive skills (Intendu®) has been developed . It is a software which is able to interact with patients through a video monitoring feedback (Kinect®), enhancing brain plasticity of patients with brain dysfunction.
Aim of the study:
To evaluate whether an adaptive motion-interaction video game can improve processing speed and executive functions in premature children.
Methods:
35 children born prematurely (23-36.5 W) aged 4-6 year-old with reduced processing speed, will be invited to participate if they meet the inclusion criteria. They will be submitted to 4-5 weeks intensive training with Intendu®, (4-5 sessions per week, for a total of 20 sessions) lasting 15 minutes each, in the presence of a tutor (a psychologist expert in premature children). A control group of 35 children (no training) with the same characteristics (gestational age, cognitive profile, socio-economic status) will be available. Before and after the training/or no training the participants, in addition to the scheduled follow-up assessment, will be evaluated with two WPPSI-III®-Wechsler Preschool and Primary Scale of Intelligence subtests (Coding and Symbol search) and one Nepsy II® domain-A developmental Neuropsychological Assessment (attention and executive function). Teacher and parents evaluations will be also considered (school reports and Child Behavior Checklist - questionnaire)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training | Experimental | Device: Intenduchildren submitted to the Intendu training with motion based cognitive video games software |
| no training | No intervention | –children not submitted to the training, entering the study as a control group |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- born between 23-36.5 weeks of gestation
- age between 4 and 0 month -6 years and 11 months
- included in the V, Buzzi children's Hospital follow-up program
- resident no further than 20 km from the V. Buzzi Children's Hospital
- with WPPSI-III processing speed quotient of 91 or less
Key exclusion criteria (1 listed)
- children affected by epilepsy
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 |
|---|---|---|
| Intenduintensive training with Motion Based Cognitive Video Games Software | Device | training |
Primary outcome
change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient
Time frame: assessment at baseline (time 0) and at the end of the training (after 4 weeks)
the achievement of at least 10 points change of WPPSI® Processing Speed Quotient (subtests: Coding and Symbol search) will be considered significant
change in scaled scores of Nepsy II® (developmental Neuropsychological Assessment) attention and executive function domain
Time frame: assessment at baseline (time 0) and at the end of the training (after 4 weeks)
the achievement of at least 3 points change in scaled scores of Nepsy II® attention and executive function domain
Results and safety
The study was stopped early (reason given: Due to SARS-Cov-2 emergency we were unable to recruit the expected number of children. We will analyze the available data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Background: PubMed 19081519Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009 Jan;8(1):110-24. doi: 10.1016/S1474-4422(08)70294-1.
- Background: PubMed 17625996Johnson S. Cognitive and behavioural outcomes following very preterm birth. Semin Fetal Neonatal Med. 2007 Oct;12(5):363-73. doi: 10.1016/j.siny.2007.05.004. Epub 2007 Jul 10.
- Background: PubMed 20485453Dye MW, Green CS, Bavelier D. Increasing Speed of Processing With Action Video Games. Curr Dir Psychol Sci. 2009;18(6):321-326. doi: 10.1111/j.1467-8721.2009.01660.x.
- Individual participant dataSharing planned: No. protocol of the study and patient data
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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.
Barbara Scelsa, MD principal investigator
V. Buzzi Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intendu in people with Executive Functions, run by Vittore Buzzi Children's Hospital 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Apr 2021. 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 was stopped early (reason given: Due to SARS-Cov-2 emergency we were unable to recruit the expected number of children. We will analyze the available data). Results are not available in the source record.
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?
change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient (time frame: assessment at baseline (time 0) and at the end of the training (after 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03639298, which also lists 3 linked publications.
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 5 Apr 2021.