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临床试验/NCT03338478
NCT03338478已完成不适用

Effect of Antiepileptic Drugs on Balance and Reaction Time

Erik J. Kobylarz2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Balance

研究概览

简要总结

Patients with epilepsy exercise less than the general population. A barrier to exercise may be the effect of antiepileptic drugs on balance and reaction time. This proposal endeavors to study the effect of two common antiepileptic drugs (levetiracetam and lamotrigine) on balance and reaction time using a Wii balance board and reaction time test. This will be tested at descending doses in an epilepsy monitoring unit. Drug levels will be monitored, as well as center of pressure, and reaction time.

详细描述

Patients with epilepsy (PWE) exercise less compared to the general population. One barrier to participation in exercise is the subtle effect of anti epileptic drugs (AEDs) on balance and reaction time. Information on these measures in PWE is scarce, although previous data does suggest a detrimental effect. The objective of this trial is to study balance and reaction time in patients taking common AEDs. The investigators plan to study the effect of levetiracetam and lamotrigine on balance and reaction time. By studying patients in the epilepsy monitoring unit who are undergoing medication taper and withdrawal, the investigators can observe the effects of varying doses of these drugs within a single subject and also compare these data points to age matched controls. A Wii balance board (WBB) will be used to measure balance. It is hypothesized that levetiracetam and lamotrigine will elicit a dose-dependent, detrimental effect on balance and reaction time.

Patients admitted to the epilepsy monitoring unit who are currently taking levetiracetam or lamotrigine either in monotherapy will be recruited for the study. The target enrollment is 20 PWE, and 20 healthy controls.

For the PWE in the study, baseline AED blood levels will be obtained at baseline. The WBB has cells which detect load shifts in the body. Participants will stand on the WBB and remain as steady as possible. First on both feet with eyes open for 30 seconds, and then on both feet with eyes closed for 30 seconds, then on one foot with eyes open for 10 seconds, and then on one foot with eyes closed for 10 seconds. Each task will have 3 trials, with adequate break between.

Visit 2 will occur following weaning of AEDs. The investigators will measure center of pressure and reaction time testing similar to visit one. Blood AED levels will be checked at three half lives of the medication. This will be taken within 8 hours of visit 2.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Focal or generalized epilepsy
  • On a stable dose of AEDs defined by no medication changes within the last month.
  • On levetiracetam or lamotrigine monotherapy

排除标准

  • Inability to stand independently for 30 seconds
  • Peripheral neuropathy
  • History of stroke or previous brain surgery
  • Seizure within last 24 hours

结局指标

主要结局

Balance

时间窗: Up to six weeks.

Balance measured by Wii Balance Board (WBB). The WBB has cells which detect load shifts in the body. Participants stand on both feet with eyes open; on both feet with eyes closed; on one foot with eyes open; and on one foot with eyes closed. Balancia software will be used to analyze the information.

Reaction Time

时间窗: Up to six weeks.

Participants will use dominant hand on mouse to click as quickly as possible in response to a prompt on a computer screen. Five trials will be conducted at each visit.

次要结局

未报告次要终点

研究者

发起方
Erik J. Kobylarz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Erik J. Kobylarz

Fellow, GME Epilepsy

Dartmouth-Hitchcock Medical Center

研究点 (2)

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