Impact of Selective Cyclooxygenase-2 Inhibitor, Celecoxib on Cortical Excitability and Electrophysiological Property in Brain of Healthy Volunteer: Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer
研究概览
简要总结
the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
详细描述
Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trauma, ischemia, hypoxia and seizure), innate immunity and subsequent adaptive immunity subserve the robust inflammatory cascades, leading to excitatory synaptic networks. Cellular elements, such as neuron, microglia as well as inflammatory molecules (cyclooxygenase2, interleukin-1, tumor necrosis factor-alpha, etc) play essential roles in enhancing this process.
In line with these, compelling evidences in animal studies in epilepsy field indicate that celecoxib (COX-2 inhibitor) has anticonvulsant actions, although its mechanisms are not fully understood. Thus, oral administration of Celecoxib in human has a high potential to suppress the neuronal excitability. As a milestone for the big picture, current study is going to prove the changes of cortical excitability evoked by transmagnetic stimulation (TMS) and electroencephalographic properties revealed by EEG in healthy volunteer, given that power spectral analysis of EEG and several parameters of TMS , can detect the small changes of neuronal activities by celecoxib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged between 20 and 50 years.
- •Signed voluntary written informed consent.
- •Body mass index between 16.0 and 30.0 kg/m2.
排除标准
- •History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
- •History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
- •History of any kind of medication(s) within 1 week before screening.
- •Presence of clinically significant electrocardiogram abnormality at screening.
- •aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
- •Serum creatinine levels : greater than 1.5 × upper normal limit.
- •Platelet counts lower than 100,000 / μL
- •Serum potassium : greater than 5.5 mmol/L
- •Female who is pregnant, breastfeeding, or intends to become pregnant.
- •History of noncompliance with medications.
- •History of alcohol abuse.
- •Participation in drug study within 30 days before screening.
- •Galactose intolerance
研究组 & 干预措施
Celecoxib for electroencephalography
Electroencephalography will be performed before and after celecoxib administration
干预措施: Celecoxib (Drug)
Placebo for electroencephalography
Electroencephalography will be performed before and after placebo administration
干预措施: Placebo (Drug)
Celecoxib for motor evoked potential
Motor evoked potential will be measured before and after celecoxib administration
干预措施: Celecoxib (Drug)
Placebo for motor evoked potential
Motor evoked potential will be measured before and after placebo administration
干预措施: Placebo (Drug)
结局指标
主要结局
Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer
时间窗: 4 hours after medical treatment
Power spectrum will be measured by electroencephalography
Cortical excitability alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer
时间窗: 7 days after medical treatment
Cortical excitability will be measured by transmagnetic stimulation
次要结局
- Power spectral change by celecoxib in different locations and different frequency band.(4 hours and 7 days after medical treatment)