Effect of Levetiracetam on Brain Excitability
Effects of Levetiracetam on Cortical Excitability in Humans
This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam, on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently from other anti-seizure drugs, but its mechanism is not well understood. This study may provide insight into a new protection mechanism against seizures as well as the effect of the drug on cortical excitability.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates will have a medical history taken and undergo physical and neurological examinations.
Participants will undergo two different procedures in four separate sessions. One procedure (cortical excitability) involves taking either levetiracetam or placebo (a look-alike inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very brief electrical current is passed through an insulated coil wire placed on the scalp. The magnetic pulse travels through the scalp and skull, causing small electrical currents in the cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes. During the study, subjects may be asked to make movements, do simple tasks or tense muscles. Electrical activity of the muscles will be recorded using electrodes taped to the skin over the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of a metronome every two seconds and then completely relaxes the hand until the next beat.
Subjects will be tested on four different days at least 72 hours apart. Each session will last about 3 to 4 hours.
Approximate schedule for cortical excitability testing:
TMS (study 1)
Take levetiracetam or placebo
TMS (study 2) < 60 minutes after drug or placebo
TMS (study 3) < 120 minutes after drug or placebo
Approximate schedule for pinch-training related changes:
Take levetiracetam or placebo
TMS and pinch power measurement < 60 minutes after drug or placebo
Pinch training for 30 minutes
TMS and pinch power measurement
Sample schedule:
Session 1 < LTC and cortical excitability testing
Session 2 < Placebo and cortical excitability testing
Session 3 < LTC and pinch-training related changes
Session 4 < Placebo and pinch-training related changes
研究概览
地位
详细说明
研究类型
注册
联系人和位置
学习地点
-
-
Maryland
-
Bethesda、Maryland、美国、20892
- National Institute of Neurological Disorders and Stroke (NINDS)
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
This study will be done on normal volunteers.
Subjects will be adults older than age 18.
No development of a serious medical condition.
Compliance with protocol evaluations or examinations.
学习计划
研究是如何设计的?
合作者和调查者
出版物和有用的链接
一般刊物
- Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference (EILAT IV). Epilepsy Res. 1999 Mar;34(1):1-41. doi: 10.1016/s0920-1211(98)00108-9.
- Wulfert E, Hanin I, Verloes R. Facilitation of calcium-dependent cholinergic function by ucb L059, a new "second generation" nootropic agent. Psychopharmacol Bull. 1989;25(3):498-502.
- Loscher W, Honack D. Profile of ucb L059, a novel anticonvulsant drug, in models of partial and generalized epilepsy in mice and rats. Eur J Pharmacol. 1993 Mar 2;232(2-3):147-58. doi: 10.1016/0014-2999(93)90768-d.
研究记录日期
研究主要日期
学习开始
初级完成
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.