Efficacy Study of a Neuropsychological Rehabilitation Intervention for Children With Non-symptomatic Epilepsy

March 24, 2020 updated by: IRCCS Eugenio Medea

Studio di Efficacia di Percorsi di Riabilitazione Neuropsicologica Tramite Piattaforma Lumosity: Evidenze Comportamentali e Neurofisiologiche in Pazienti Con Epilessia Non Sintomatica in età Pediatrica

Patients with non-symptomatic epilepsy, even in the presence of a normative cognitive functioning, present different levels of neuropsychological weaknesses, especially in executive functions and social competences. Such difficulties can significantly influence academic achievement and social inclusion. To date, there is limited evidence on small samples that training focusing on executive functions, also through tele-rehabilitation methods, may be effective in limiting these difficulties. Therefore, the purpose of this research project is to evaluate the effectiveness of a training of the executive functions (administered via the Lumosity platform) in patients with non-symptomatic focal and generalized epilepsy. A cognitive and behavioral assessment will be performed before and after the treatment to evaluate its efficacy. Moreover, a predefined neurophysiological marker will be recorded before and after treatment to detect changes in cortical activity which may reflect expected treatment effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

First, all eligible patients will be screened for inclusion and exclusion and will be assigned to the experimental group and the control group. The experimental group will participate in a remote rehabilitation program via Lumosity platform, providing video-games aimed at strengthening specific cognitive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. The control group will watch a series of animated / TV shows, again for 30 minutes a day, 5 days a week, for 8 weeks. Once a week the patient (or his family) will be contacted by the researcher to check the progress of the treatment. All patients will be evaluated within a week before the start of treatment and after the end of treatment with a standardized neuropsychological assessment battery (NEPSY-II) designed to evaluate the effects of the treatment. Patients (or their parents according to participants' age) will also compile a questionnaire to assess behavioral problems (CBCL); a questionnaire for the assessment of cognitive functions in an ecological context (BRIEF-2); a quality of life questionnaire (TACQOL) and ad-hoc treatment appreciation questionnaire. In addition to the cognitive-behavioral assessment, specific parameters of cortical activity will be recorded (via EEG), in order to evaluate any changes in predefined neurophysiological markers able to reflect the effects of the treatment. Evidence gathered from the literature reports that the relationship between theta and beta waves (the so-called theta/beta ratio) may be considered an index of a behavioral adaptation deficit in populations with poor executive control. Therefore, this index appears to be the ideal candidate to detect changes in cortical activity which may underlay behavioral effects of home rehabilitation treatment. Thus, resting-state cortical activity will be recorded before and after the treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of non-symptomatic epilepsy;
  • Absence of intellectual disability (total IQ> 70);
  • Absence of significant visual, auditory or motor impairments that may prevent the use of the computerized training;
  • Basic ability to use PC.

Exclusion Criteria:

  • Presence of psychiatric comorbidity and / or behavioral disturbances that may hamper the participation to training sessions;
  • Diagnosis of photosensitive epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Home rehabilitation training
Behavioral: Home rehabilitation training
The rehabilitation training will be provided via Lumosity platform. Participants will be asked to play computer video-games aimed at strengthening specific sub-functions pertaining to the macro area of executive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. Specifically, 20 games out of a total of 64 available games provided by the platform have been selected. The selected games are aimed at training 4 cognitive skills: memory, attention, cognitive flexibility and problem solving. In particular, 5 different games were chosen for each cognitive ability.
Active Comparator: Home control activity
Behavioral: Home control activity
The control group will watch a series of animated / TV shows suitable for the sample age, again for 30 minutes a day, 5 days a week, for 8 weeks. The videos will be provided by the experimenter and participants will watch them on their personal computer. At the end of each videos, participants will answer a series of multiple-choice questions aimed at evaluating the attention deployed to the content of the videos.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NEPSY-II Neuropsychological Battery
Time Frame: baseline

Assessment of executive functions, language, memory and visuo-spatial skills

Subscales (all subscales range from 1 to 19 scalar scores):

  • Design fluency, raw score 0/70
  • Auditory attention, 0/30 and Response Set 0/36
  • Inhibition (denomination 0/80 - 0/360') (inhibition 0/80 - 480') (switching 0/80 - 480') REVERSE (higher raw scores indicate worse perfomance)
  • Animal sorting, 0/12
  • Word generation, 0/75
  • Memory for faces, 0/32
  • Word list interference (repetition 0/20; recall 0/40)
  • Imitating hand position, (0/24)
  • Visuo-motor precision (0/307; 0/360') REVERSE (higher raw scores indicate worse perfomance)
  • Manual motor sequences, 0/60
  • Affect recognition, 0/35
  • Design copying (general 0/21; motor 0/42; global 0/42; local 0/36; total specific 0/120)
  • Picture puzzles, 0/20
  • Geometric puzzles, 0/40
baseline
Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
Time Frame: baseline

Assessment of general intellectual ability. Indexes (higher T scores indicate better perfomance for all indexes)

  • Verbal Comprehension Index (40/160)
  • Fluid Reasoning Index (40/160)
  • Working Memory Index (40/160)
  • Processing Speed Index (40/160)
  • Full Scale IQ (40/160)
baseline
NEPSY-II Neuropsychological Battery (change)
Time Frame: within 1 week after intervention
Assessment of executive functions, language, memory and visuo-spatial skills
within 1 week after intervention
NEPSY-II Neuropsychological Battery (change)
Time Frame: 3 month after intervention
Assessment of executive functions, language, memory and visuo-spatial skills
3 month after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child Behavior Checklist (CBCL) (parent compiled for 6-18 years old participants)
Time Frame: baseline

Questionnaire for the assessment of emotional and behavioural problems.

The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
baseline
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Time Frame: baseline

Questionnaire for the assessment of emotional and behavioural problems.

YSR 11-18 is direcly compiled by adolescents aged 11-18 years. It provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
baseline
The Children's Quality of Life (TACQOL)
Time Frame: baseline

Questionnaire for the assessment of health-related quality of life.

Scales (higher raw scores indicate higher quality of life)

  • Body (physical functioning) 0/32
  • Motor functioning 0/32
  • Autonomy 0/32
  • Social functioning 0/32
  • Cognition 0/32
  • Emotions (positive) 0/16
  • Emotions (negative) 0/16
baseline
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent compiled for 5-10 years old participants; self-report version for 11-18 years old participants)
Time Frame: baseline

Questionnaire for the assessesment of executive function and self-regulation competence.

The BRIEF (parent version) questionnaire is aimed at assessing executive functioning at home and school and contains 63 items. Raw scores of the global scale range from 63 to 189; T scores (M = 50, SD = 10). The self-report version contains 55 items. Raw scores of the global scale range from 55 to 165; T scores (M = 50, SD = 10). Higher scores mean a worse outcome.

Subscale and Indexes

  • Inhibit
  • Shift
  • Self-Monitor
  • Emotional Control
  • Initiate
  • Working Memory
  • Plan/Organize
  • Behavioral regulation Index
  • Emotion regulation Index
  • Cognitive regulation Index
  • Global Executive Index
baseline
Theta/beta ratio
Time Frame: baseline
Low theta/beta ratio is a cortical activity considered an index of poor attentional resources. Its recording will be conducted with a 32-channels EEG system at rest (4 minutes: 2 min eyes open and 2 min eyes closed).
baseline
Child Behavior Checklist CBCL (change)
Time Frame: within 1 week after intervention

Questionnaire for the assessment of emotional and behavioural problems

The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
within 1 week after intervention
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Time Frame: within 1 week after intervention

Questionnaire for the assessment of emotional and behavioural problems.

YSR 11-18 is direcly compiled by adolescents aged 11-18 years. It provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
within 1 week after intervention
The Children's Quality of Life TACQOL (change)
Time Frame: within 1 week after intervention

Questionnaire for the assessment of health-related quality of life. Scales (higher raw scores indicate higher quality of life)

  • Body (physical functioning) 0/32
  • Motor functioning 0/32
  • Autonomy 0/32
  • Social functioning 0/32
  • Cognition 0/32
  • Emotions (positive) 0/16
  • Emotions (negative) 0/16
within 1 week after intervention
Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
Time Frame: within 1 week after intervention

Questionnaire for the assessesment of executive function and self-regulation competence.

The BRIEF (parent version) questionnaire is aimed at assessing executive functioning at home and school and contains 63 items. Raw scores of the global scale range from 63 to 189; T scores (M = 50, SD = 10). The self-report version contains 55 items. Raw scores of the global scale range from 55 to 165; T scores (M = 50, SD = 10). Higher scores mean a worse outcome.

Subscale and Indexes

  • Inhibit
  • Shift
  • Self-Monitor
  • Emotional Control
  • Initiate
  • Working Memory
  • Plan/Organize
  • Behavioral regulation Index
  • Emotion regulation Index
  • Cognitive regulation Index
  • Global Executive Index
within 1 week after intervention
Theta/beta ratio (change)
Time Frame: within 1 week after intervention
Low theta/beta ratio is a cortical activity considered an index of poor attentional resources. Its recording will be conducted with a 32-channels EEG system at rest (4 minutes: 2 min eyes open and 2 min eyes closed).
within 1 week after intervention
Ad-hoc compliance to treatment questionnaire
Time Frame: within 1 week after intervention

A 5 items of a 5-point Likert questionnaire created ad-hoc for the assessment of the compliance to the treatment.

Higher scores indicare better compliance (except for item 4)
within 1 week after intervention
Child Behavior Checklist CBCL (change)
Time Frame: 3 months after intervention

Questionnaire for the assessment of emotional and behavioural problems

The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
3 months after intervention
Youth Self Report (CBCL self-report version for 11-18 years old participants)
Time Frame: 3 month after intervention

Questionnaire for the assessment of emotional and behavioural problems.

YSR 11-18 is direcly compiled by adolescents aged 11-18 years. It provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.
3 month after intervention
The Children's Quality of Life TACQOL (change)
Time Frame: 3 months after intervention

Questionnaire for the assessment of health-related quality of life.

Scales (higher raw scores indicate higher quality of life)

  • Body (physical functioning) 0/32
  • Motor functioning 0/32
  • Autonomy 0/32
  • Social functioning 0/32
  • Cognition 0/32
  • Emotions (positive) 0/16
  • Emotions (negative) 0/16
3 months after intervention
Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
Time Frame: 3 month after intervention

Questionnaire for the assessesment of executive function and self-regulation competence.

The BRIEF (parent version) questionnaire is aimed at assessing executive functioning at home and school and contains 63 items. Raw scores of the global scale range from 63 to 189; T scores (M = 50, SD = 10). The self-report version contains 55 items. Raw scores of the global scale range from 55 to 165; T scores (M = 50, SD = 10). Higher scores mean a worse outcome.

Subscale and Indexes

  • Inhibit
  • Shift
  • Self-Monitor
  • Emotional Control
  • Initiate
  • Working Memory
  • Plan/Organize
  • Behavioral regulation Index
  • Emotion regulation Index
  • Cognitive regulation Index
  • Global Executive Index
3 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Eugenio Medea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alessandra Bardoni, MD, PhD, Scientific Institute, IRCCS E. Medea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 769

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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