Executive Functions Rehabilitation in Premature Children

Executive Functions Clinical Trial

Official title:

Premature Children-executive Functions and Training With Cognitive Motion-based Videogames (Intendu®): a Rehabilitation Project

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03639298
• Other study ID #: BS1
• Status: Terminated
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: October 20, 2020

Study information

• Verified date: March 2021
• Source: Vittore Buzzi Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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®). 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: October 20, 2020
• Est. primary completion date: September 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria: children

• 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

Exclusion Criteria:

• children affected by epilepsy

Related Conditions & MeSH terms

• Executive Functions
• Premature Birth

Intervention

Device:
• Intendu
intensive training with Motion Based Cognitive Video Games Software

Locations

Country	Name	City	State
Italy	V. Buzzi Children's Hospital	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Vittore Buzzi Children's Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Dye MW, Green CS, Bavelier D. Increasing Speed of Processing With Action Video Games. Curr Dir Psychol Sci. 2009;18(6):321-326. — View Citation

Johnson S. Cognitive and behavioural outcomes following very preterm birth. Semin Fetal Neonatal Med. 2007 Oct;12(5):363-73. Epub 2007 Jul 10. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assessment at baseline (time 0) and at the end of the training (after 4 weeks)
Primary	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	assessment at baseline (time 0) and at the end of the training (after 4 weeks)