Telerehabilitation of Working Memory in Children With Periventricular Leukomalacia and Bilateral Cerebral Palsy

NCT02342990 | Completed

• 1 other identifier: RC1/13-15_1.4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral ventricles of the brain occurring in the prenatal period, associated with a disorder of movement and posture, known as bilateral cerebral palsy. Children with PVL and bilateral cerebral palsy have spared verbal abilities, as measured by verbal Intelligence Quotient (verbal IQ) tests, while non-verbal intelligence and especially visuo-perceptual and visuo-spatial abilities are impaired. In addition some studies underline the impact of PVL also on executive function, especially in terms of working memory and in the ability to inhibit distraction. Working Memory is the ability to retain and manipulate information for brief periods of time. It is important in several complex cognitive functions, such as academic learning and in planning and organizing daily life activities. School-based activities, indeed, such as math and reading depend on a student's ability to pay attention to several instructions or information and to hold and integrate them in their mind. Recent behavioural and neurofunctional studies describes the effect of an evidence-based and computer-based training on working memory, the Cogmed Working MemoryTraining. Functional MRI show increase in parietal and prefrontal activity after this training, while the behavioural data demonstrate the generalization of this effect also on cognitive functions not directly trained, as attention, inhibition, learning and non-verbal reasoning. Cogmed Working MemoryTraining (RoboMemo®, CogMed-Cognitive Medical Systems, Stockholm, Sweden) is an online treatment comprising a number of visuo-spatial and verbal exercises that vary automatically depending on the individual child's performance in any given task. The training period is intensive and includes 25 home session for five weeks, 30-45 minutes each day. A Cogmed-trained coach monitors training progress and participants' commitment daily. Only one ongoing study has used the CogMed training in children with cerebral palsy, but without investigating the correlation between behavioural findings with neurofunctional data. The aim of this study is to analyze the effect of the working memory training with CogMed on trained and not directly trained cognitive abilities and on the changes in cortical electrophysiological reorganization during the sleep after training. The sleep analysis will be focused in particular on the slow waves activity \[frequency range of 1-4.5 Hz\] and on the sleep spindle \[frequency range of 12-14Hz\], which reflect the depth of sleep and are related to memory processes, learning and brain plasticity. The results of this project will shed light on the mechanisms of neuroplasticity, by enhancing knowledge on the neuropsychological effects of a specific working memory training and on the neurophysiological underpinnings of these behavioural effects in a clinical population of children with congenital brain lesions, as PVL.

Conditions

Periventricular Leukomalacia

Keywords

working memory training; home-based training; periventricular leukomalacia; bilateral cerebral palsy; neuropsychological profile; high density EEG; slow waves activities

Outcome Measures

Primary Outcomes (1)

• Working Memory (assessed by CogMed improvement index)

  Working Memory will be assessed by CogMed improvement index, calculated subtracting the Start Index (the mean of the three best successful trials on days 2 and 3) from the Max Index (the mean of the three best successful trials on the two best training days).

  5 weeks

Secondary Outcomes (15)

• cortical electrophysiological reorganization during the sleep (high density EEG (hdEEG)

  6 or 7 weeks

• Short-term visuospatial memory (measured by Memory for Design subtest included in the Memory and Learning domain at the NEPSY-II)

  6 or 7 weeks

• Visual Attention (Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II)

  6 or 7 weeks

• Auditory Attention (assessed by Auditory Attention and Response Set subtest)

  6 or 7 weeks

• Inhibition (assessed by Inhibition subtests included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II)

  6 or 7 weeks

Other Outcomes (4)

• child's behavior (CogMed parent rating scale questionnaire)

  6 or 7 weeks

• Mathematic abilities (assess by one of the most widely used Italian mathematic battery, Test di valutazione delle ablitià di calcolo (AC-MT)

  6 or 7 weeks

• Verbal Working memory span (assessed by the Following Instructions test provided by the CogMed program)

  3 weeks

Study Arms (2)

Cluster B

EXPERIMENTAL

After the first neuropsychological assessment (T1), children will start CogMed working memory training. Children will be retested (T2) about six or seven weeks later.

Other: Cluster B CogMed: an home-based and computer-based solution to improve working memory deficit

Cluster A

OTHER

After the first neuropsychological assessment (T1), children will not start any training. Children will be retested (T2) about six or seven weeks later and will start CogMed working memory training. The group will be again retest (T3) after six or seven weeks after ended training.

Other: Cluster B CogMed: an home-based and computer-based solution to improve working memory deficit; Other: Cluster A No training. Delay start of CogMed

Interventions

Cluster B CogMed: an home-based and computer-based solution to improve working memory deficit OTHER

CogMed: an home-based and computer-based solution to improve working memory deficit

Cluster A; Cluster B

Cluster A No training. Delay start of CogMed OTHER

No training will be provided after T1 time point. Cluster A will start the CogMed training after the assessment at the T2 time point

Cluster A

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• PVL documented at brain MRI performed after age 2 years
• level I to III at the Manual Ability Classification System (MACS)
• IIntelligence Quotient above 80 in either verbal or non-verbal domains, as assessed by Wechsler preschool and primary scale of intelligence (WPPSI-III), Wechsler intelligence scale of children (WISC-III or WISC-IV) in the last year prior to recruitment

You may not qualify if:

• absence of a psychiatric disorder diagnosis or sensory deficits that preclude testing
• absence of drug-resistant epilepsy

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• University of Pisa: collaborator
• University of Milan: collaborator

Study Sites (1)

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

Location

MeSH Terms

Conditions

Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Giovanni Gioni, MD

  IRCCS-Stella Maris, Calambrone, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2015
• First Posted: January 21, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

IT (1)