Electrophysiologic Property of Brain
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGCelecoxib
DRUGPlacebo
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Power spectral change by single oral dose of celecoxib (400mg once) in healthy volunteer | 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 | 7 days after medical treatment | Cortical excitability will be measured by transmagnetic stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Power spectral change by celecoxib in different locations and different frequency band. | 4 hours and 7 days after medical treatment | Power spectrum will be measured by electroencephalography |
Countries
South Korea
Outcome results
None listed