Studio di Efficacia di Percorsi di Riabilitazione Neuropsicologica Tramite Piattaforma Lumosity: Evidenze Comportamentali e Neurofisiologiche in Pazienti Con Epilessia Non Sintomatica in età Pediatrica
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 主要终点
- NEPSY-II Neuropsychological Battery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Presence of psychiatric comorbidity and / or behavioral disturbances that may hamper the participation to training sessions;
- •Diagnosis of photosensitive epilepsy.
结局指标
主要结局
NEPSY-II Neuropsychological Battery
时间窗: 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
Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
时间窗: 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)
NEPSY-II Neuropsychological Battery (change)
时间窗: 3 month after intervention
Assessment of executive functions, language, memory and visuo-spatial skills
次要结局
- 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)(3 month after intervention)
- 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)
- Child Behavior Checklist CBCL (change)(3 months after intervention)
- The Children's Quality of Life TACQOL (change)(3 months after intervention)
- Behavior Rating Inventory of Executive Function (BRIEF-2) (change)(3 month after intervention)
- Theta/beta ratio (change)(within 1 week after intervention)
- Ad-hoc compliance to treatment questionnaire(within 1 week after intervention)