Clinical trial NCT04292093: Efficacy Study of a Neuropsychological Rehabilitation Intervention for Children With Non-symptomatic Epilepsy
Official title: Studio di Efficacia di Percorsi di Riabilitazione Neuropsicologica Tramite Piattaforma Lumosity: Evidenze Comportamentali e Neurofisiologiche in Pazienti Con Epilessia Non Sintomatica in età Pediatrica
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Children
Rehabilitation
Executive Functions
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NEPSY-II Neuropsychological Battery
timeFrame: baseline
measure: Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
timeFrame: baseline
measure: NEPSY-II Neuropsychological Battery (change)
timeFrame: within 1 week after intervention
measure: NEPSY-II Neuropsychological Battery (change)
timeFrame: 3 month after intervention
Secondary outcomes:
measure: Child Behavior Checklist (CBCL) (parent compiled for 6-18 years old participants)
timeFrame: baseline
measure: Youth Self Report (CBCL self-report version for 11-18 years old participants)
timeFrame: baseline
measure: The Children's Quality of Life (TACQOL)
timeFrame: baseline
measure: 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)
timeFrame: baseline
measure: Theta/beta ratio
timeFrame: baseline
measure: Child Behavior Checklist CBCL (change)
timeFrame: within 1 week after intervention
measure: Youth Self Report (CBCL self-report version for 11-18 years old participants)
timeFrame: within 1 week after intervention
measure: The Children's Quality of Life TACQOL (change)
timeFrame: within 1 week after intervention
measure: Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
timeFrame: within 1 week after intervention
measure: Theta/beta ratio (change)
timeFrame: within 1 week after intervention
measure: Ad-hoc compliance to treatment questionnaire
timeFrame: within 1 week after intervention
measure: Child Behavior Checklist CBCL (change)
timeFrame: 3 months after intervention
measure: Youth Self Report (CBCL self-report version for 11-18 years old participants)
timeFrame: 3 month after intervention
measure: The Children's Quality of Life TACQOL (change)
timeFrame: 3 months after intervention
measure: Behavior Rating Inventory of Executive Function (BRIEF-2) (change)
timeFrame: 3 month after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Scientific Institute, IRCCS E. Medea
name: Alessandra Bardoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: