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

NCT ID: NCT04292093

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-02-28

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Home rehabilitation training

Home rehabilitation training

Group Type: EXPERIMENTAL

Home rehabilitation training

Intervention Type: BEHAVIORAL

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.

Home control activity

Home control activity

Group Type: ACTIVE_COMPARATOR

Home control activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandra Bardoni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Scientific Institute, IRCCS E. Medea

Central Contacts

Alessandra Bardoni, MD, PhD

Role: CONTACT

alessandra.bardoni@lanostrafamiglia.it

+39 031877111

Other Identifiers

769

Identifier Type: -

Identifier Source: org_study_id