Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT04292093
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.
Study:
NCT04292093
Study Brief:
Protocol Section:
NCT04292093