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Trial record 1 of 27 for:    "Periventricular Leukomalacia"
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Telerehabilitation of Working Memory in Children With Periventricular Leukomalacia and Bilateral Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02342990
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
University of Pisa
University of Milan
Information provided by (Responsible Party):
IRCCS Fondazione Stella Maris

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.


Condition or disease Intervention/treatment Phase
Periventricular Leukomalacia 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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telerehabilitation of Working Memory in Children With Periventricular Leukomalacia and Bilateral Cerebral Palsy, a Neuropsychological and Electrophysiological (High-density EEG) Study
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cluster B
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
CogMed: an home-based and computer-based solution to improve working memory deficit

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

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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 subtest included in the Visuospatial processing domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.

  12. Finger Tapping (assessed by Finger Tapping subtest included in the Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
    the ability to imitate a series of finger movements with the dominant and non-dominant hand will be assessed by Finger Tapping subtest included in the Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.

  13. Imitating hand positions ( evaluated by Imitating hand position subtest included in the Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
    the ability to imitate hand and finger positions will be evaluated by Imitating hand position subtest included in the Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.

  14. Visuo-motor Precision (assessed by Visuomotor Precision subtest included in Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
    visuo-motor control will be assessed by Visuomotor Precision subtest included in Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II). Raw scores for accuracy and speed will be calculated.

  15. Manual Motor Sequences (evaluated by Manual Motor Sequences included in the Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II) [ Time Frame: 6 or 7 weeks ]
    the ability to imitate and planning hand movements will be evaluated by Manual Motor Sequences included in the Sensorimotor skills domain at the Developmental Neuropsychological battery (NEPSY-II). Raw score will be calculated.


Other Outcome Measures:
  1. child's behavior (CogMed parent rating scale questionnaire) [ Time Frame: 6 or 7 weeks ]
    CogMed parent rating scale questionnaire will be filled out by the parents for monitoring child's behavior before and after training period. The questionnaire collect quantitative data on changes in the child's behaviour measuring raw scores for the follows behavioural area: attention, hyperactive and impulsive. This questionnaire will be filled only by parents of school-age children, as provided by CogMed.

  2. Mathematic abilities (assess by one of the most widely used Italian mathematic battery, Test di valutazione delle ablitià di calcolo (AC-MT) [ Time Frame: 6 or 7 weeks ]
    Mathematic abilities will be assess by one of the most widely used Italian mathematic battery, Test di valutazione delle ablitià di calcolo (AC-MT). For this project will be administered only the second part of battery, called individual condition, which include different subtests to assess mental and written calculation, arithmetic facts and numerical knowledge. Standard score will be provided.

  3. Verbal Working memory span (assessed by the Following Instructions test provided by the CogMed program) [ Time Frame: 3 weeks ]
    The Verbal working memory span will be assessed by the Following Instructions test provided by the CogMed program. In the Following Instruction test the child listen to a set of instructions and then click on or drag objects seen on the screen in a specific order. Test scores are expressed in span scores.

  4. Visuospatial working memory span (assessed by the Working Memory test provided by the CogMed program) [ Time Frame: 3 weeks ]
    The visuospatial working memory span will be assessed by the Working Memory test provided by the CogMed program. The Working Memory test is an exercise where the child have to identify the different shape from a set of three and remember its location. Test scores are expressed in span scores.



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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342990


Locations
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Italy
IRCCS Stella Maris Foundation
Calambrone, Pisa, Italy, 56128
Sponsors and Collaborators
IRCCS Fondazione Stella Maris
University of Pisa
University of Milan
Investigators
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Study Chair: Giovanni Gioni, MD IRCCS-Stella Maris, Calambrone, Italy

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Responsible Party: IRCCS Fondazione Stella Maris
ClinicalTrials.gov Identifier: NCT02342990     History of Changes
Other Study ID Numbers: RC1/13-15_1.4
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by IRCCS Fondazione Stella Maris:
working memory training
home-based training
periventricular leukomalacia
bilateral cerebral palsy
neuropsychological profile
high density EEG
slow waves activities

Additional relevant MeSH terms:
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Cerebral Palsy
Leukomalacia, Periventricular
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases