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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Telerehabilitation of Working Memory in Children With Periventricular Leukomalacia and Bilateral Cerebral Palsy, a Neuropsychological and Electrophysiological (High-density EEG) Study

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 mi

Detailed Summary:

The procedures implemented to register patients data will include the following steps:

  • The quality assurance plan will provide: - to verify that all clinical fields, necessary to include and select patients, are available in the registry (e.g. type of cerebral palsy; MRI documentation, age); - to monitor that patients' contact information are available as well as testing materials and software; - to set team meetings to uniform recruitment procedure, data collection and registration.
  • Data checks will be conducted by two or more researches from the team;
  • Source data verification: both paper and electronic case report forms will be used and mutually checked.
  • Data dictionary: Pre-post measures will be chosen by the team and described in a report form together with references and normative data.
  • Procedure Standardization to address registry operations: Researches will co-work in patient recruitment and will attribute an identification number to each patient enrolled according to the inclusion and exclusion criteria evaluated by the neuropsychiatric team and described below. All researchers will be trained to register data in an internal database and to note the presence of adverse events. The researcher providing the training will assure comprehension and subscription of the written consent. Consent form will be discussed by the team in order to provide explicit and clear instructions on the training protocol to parents and patients.
  • Calculation of sample size: Sample size, to specify the number of participants necessary to demonstrate the training effect, will be calculated from the training effect size between the Start index and the Max index provided by CogMed training
    Sponsor: IRCCS Fondazione Stella Maris

    Current Primary Outcome: Working Memory (assessed by CogMed improvement index) [ Time Frame: 5 weeks ]

    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).


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • cortical electrophysiological reorganization during the sleep (high density EEG (hdEEG) [ Time Frame: 6 or 7 weeks ]
      the electrophysiological signals will be register by high density EEG (hdEEG) during around one hour of sleep. The changing in the slow waves activity [frequency range of 1-4.5 Hz] and in the sleep spindle [frequency range of 12-14Hz], strongly associated with memory and learning mechanisms, will be analyze.
    • Short-term visuospatial memory (measured by Memory for Design subtest included in the Memory and Learning domain at the NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      Visuospatial memory assessment will be measured by Memory for Design subtest included in the Memory and Learning domain at the NEPSY-II. This subtest requires recognizing some designs and recalling its position on a grid (comprising from 4 to 10 designs) after a previous learning phase, both in immediately and delayed (after about 15-25 minutes) conditions. A raw scores for both immediately and delay conditions will be calculated.
    • Visual Attention (Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      Visual attention is a visual search subtest included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.
    • Auditory Attention (assessed by Auditory Attention and Response Set subtest) [ Time Frame: 6 or 7 weeks ]
      sustained auditory attention and the ability to shift and maintain new and complex set of rules, involving the inhibition of previously learned responses, will be assessed by Auditory Attention and Response Set subtest, included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II). Raw scores will be calculated.
    • Inhibition (assessed by Inhibition subtests included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      the ability to inhibit automatic responses in favour of novel responses and to switch between response types will be assessed by Inhibition subtests included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II). Raw scores for accuracy and response time will be calculated.
    • phonological processing (assessed by Phonological processing subtest included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      phonemic awareness and verbal working memory will be assessed by Phonological processing subtest included in Executive Function/Attention domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.
    • visuo-graphical skills (assessed by Design Copy subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      the ability to copy complex geometric figures will be assessed by Design Copy subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated
    • visuo-constructional skills (evaluated by Block Construction subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      the ability to copy two-dimensional block models in three-dimensional representations with blocks will be evaluated by Block Construction subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.
    • rotate mental representation (assessed by Geometric Puzzle subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      the ability to recognize rotated geometric shapes placed on a grid from a series of distractors will be assessed by Geometric Puzzle subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated
    • visuo-spatial skills (evaluated by Route Finding subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      the ability to identify the correct path leading to a house on a schematic map will be evaluated by Route Finding subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.
    • visuo-perceptual skills (assessed by Arrows subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
      visuo-perceptual abilities will be assessed by Arrows su

      Original Secondary Outcome: Same as current

      Information By: IRCCS Fondazione Stella Maris

      Dates:
      Date Received: January 10, 2015
      Date Started: March 2014
      Date Completion:
      Last Updated: February 23, 2016
      Last Verified: February 2016