Investigating The Effect Of Cognitive Rehabilitation On Cognitive Impairment Associated With Antiseizure Medications In Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- MoCA
研究概览
简要总结
It is clear that studies on cognitive rehabilitation in epilepsy patients mostly focus on patients undergoing epilepsy surgery and are largely classified according to the type of epilepsy. The main purpose of this study is to determine whether cognitive impairments associated with antiepileptic drugs develop in epilepsy patients using neuropsychological tests and event-related potentials, and if such an impairment is present, to investigate whether cognitive rehabilitation is beneficial.
详细描述
Patients who were planned to start monotherapy were first included in the study by performing a face-to-face MoCA test. After the MoCA test, experienced neurologists measured event-related potentials, including P300 and N200 potentials and N2P3 amplitudes, in the electrophysiology laboratory. Patients for each drug were randomly assigned to the no cognitive rehabilitation group (A) or the cognitive rehabilitation group (B). At the end of the second month, MoCA test and event-related potential measurements were performed again in both groups, and the results were analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosis of epilepsy, -
- •Before monotherapy had started
排除标准
- •diagnosis of psychogenic non-epileptic seizures,
- •epileptic patients currently receiving antiepileptic drugs,
- •epileptic patients exhibiting cognitive dysfunction
- •epileptic patientswith dementia
结局指标
主要结局
MoCA
时间窗: 2 months
The Montreal Cognitive Assessment (MoCA) is a 30-point screening test that takes approximately 10 minutes to administer. It assesses executive functioning, visuospatial abilities, memory, attention, working memory, language, and orientation. It has high sensitivity and specificity. the maximum score is 30. Higher scores mean a better outcome.
Cognitive Event Related Potentials
时间窗: 2 months
The standardized recording protocol was utilized to acquire reliable and consistent Event-Related Potentials (ERP) data for a comprehensive evaluation of the brain's response to auditory stimuli. In the analysis of potentials, the amplitude between the N200 and P300 was measured from the N200 peak to the P300 peak. The latencies of the N200 and P300 potentials were also determined by identifying the midpoint of each potential (latencies in miliseconds (ms) and amplitudes in microvolt (uV))
次要结局
未报告次要终点
研究者
Omer Karadas
Prof.Dr.Omer Karadas
Gulhane Training and Research Hospital