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

NCT04292093 | Unknown

• 1 other identifier: 769
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

Epilepsy; Children; Rehabilitation; Executive Functions

Outcome Measures

Primary Outcomes (4)

• NEPSY-II Neuropsychological Battery

  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)

  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)

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

  within 1 week after intervention

• NEPSY-II Neuropsychological Battery (change)

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

  3 month after intervention

Secondary Outcomes (15)

• Child Behavior Checklist (CBCL) (parent compiled for 6-18 years old participants)

  baseline

• Youth Self Report (CBCL self-report version for 11-18 years old participants)

  baseline

• The Children's Quality of Life (TACQOL)

  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)

  baseline

• Theta/beta ratio

  baseline

Study Arms (2)

Home rehabilitation training

EXPERIMENTAL

Home rehabilitation training

Behavioral: Home rehabilitation training

Home control activity

ACTIVE COMPARATOR

Home control activity

Behavioral: Home control activity

Interventions

Home rehabilitation training 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 rehabilitation training

Home control activity 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.

Home control activity

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alessandra Bardoni, MD, PhD

  Scientific Institute, IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Bardoni, MD, PhD

CONTACT

+39 031877111; alessandra.bardoni@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 2, 2020
• Study Start: May 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 26, 2020

Record last verified: 2020-03