Cognitive Effects of Treatment of Interictal Discharges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment
研究概览
简要总结
The purpose of this study is to determine if levetiracetam (for patients with focal seizures) or lamotrigine (for patients with generalized seizures) reduces the occurrence of interictal discharges. The study investigates the possible correlation between reduction of interictal discharges and improved cognitive performance.
详细描述
Subjects with seizures will be studied with electroencephalography (EEG) and offered medication for prevention of recurrent seizures. Those with focal seizures will be treated with levetiracetam, and those with generalized seizures will be treated with lamotrigine. Subjects will undergo repeated EEG with concurrent cognitive testing before and after initiation of treatment. The proposed study tests 3 hypotheses: 1. that treatment with levetiracetam will reduce focal interictal epileptiform activity, 2. that treatment with lamotrigine will reduce generalized interictal epileptiform activity, and 3. that the extent of interictal epileptiform activity is inversely associated with performance on neuropsychological batteries and computerized cognitive testing. Repeated cognitive/neuropsychological testing obtained at steady state of the study drug and again after approximately 2 months on the final dosage will serve to evaluate the timecourse of potential cognitive benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Non-native English speaking and/or multilingual
- •Frequent seizures, since seizures themselves impair cognitive function and present a confounding variable. Subjects may have no more than one seizure or one cluster of seizures per month, with a cluster of seizures including more than one seizure, but between which the patient returns to baseline. The cluster may occur over no more than two consecutive days in one month.
- •Seizure(s) must not have occurred within 3 days of enrollment and testing.
- •Those with focal seizures who have evidence of renal disease (creatinine clearance less than 80) will be excluded from participation, as levetiracetam is cleared by the kidney.
- •Those with focal seizures who have neutrophil counts <1000/microliter will be excluded from participation, as levetiracetam may lower white blood cell counts.
- •Those with focal seizures and irritability or mood swings will not be eligible for participation, as levetiracetam may exacerbate these symptoms. This will be determined by self-report, information obtained from the referring physician and medical record.
- •Those with generalized seizures who have moderate to severe liver dysfunction (Child-Pugh Grades B and C) will be excluded from participation, as lamotrigine is cleared by the liver and the proposed dosing may not be tolerable in this population. This will be determined by self-report, information obtained from the referring physician, a comprehensive metabolic panel (routinely obtained in new-onset seizures) and the medical record.
- •Subjects who are pregnant will not be eligible to take part in the study, as levetiracetam and lamotrigine are classified as Pregnancy Category C drugs and may pose risk to the fetus. Women of childbearing potential will have a urine pregnancy test prior to participation in the study. The urine pregnancy test will be repeated at the final study visit. Subjects with epilepsy who are of childbearing potential must use acceptable methods of birth control during the study, to be continued until one month after discontinuation of the study drug. If a subject does become pregnant during this time period, she must notify the investigators.
- •Women who are breastfeeding may not participate in this study. Levetiracetam and lamotrigine may pass into the breastmilk of nursing mothers, posing a risk to the baby.
- •Hypersensitivity to lamotrigine, levetiracetam or any components of these products
研究组 & 干预措施
Levetiracetam
12 individuals with epilepsy, 6 of whom experience infrequent focal epileptiform discharges and 6 of whom experience frequent focal discharges. These individuals will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.
干预措施: levetiracetam (Drug)
Lamotrigine
12 individuals with epilepsy, 6 of whom experience infrequent generalized discharges and 6 of whom experience frequent generalized discharges. These individuals will be treated with lamotrigine (LMT). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LMT on discharge frequency, discharge duration, and cognitive task performance.
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment
时间窗: 1 and 11 weeks
This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls.
次要结局
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span(1 and 11 Weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE(1 and 11 weeks)
- Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)(1 and 11 weeks)
研究者
Beth Ami Leeman, MD
Principal Investigator
Massachusetts General Hospital