INTRODUCTION:A seizure represents the clinical expression ofabnormal, excessive, synchronous discharges of neurons residing primarily incerebral cortex. Epilepsy considered to be a disease of the brain defined byany of the following conditions: (1) At least, two unprovoked (or reflex)seizures occurring >24 h apart; (2) one unprovoked (or reflex)seizure and a probability of further seizures similar to the general recurrencerisk (at least 60%) after two unprovoked seizures, occurring over the next 10years; (3) diagnosis of an epilepsysyndrome.CreatineKinase has been a standard investigating parameter in the field of seizures (Epilepsy).
The current research focuses primarily in understanding the relationshipbetween Total CK and seizures and in turn assessing the intricate details ofthe same. The agenda for the current research study has been to effectivelyassess the role of Total CK in seizures and in turn evaluate the pharmacologicaleffects of various anti-epileptic drugs used in order to manage the medicalcondition of seizures. As CK is also a direct indicator of extent ofrhabdomyolysis the study aims to predict and prevent acute renal failure and inturn act as a precautionary entity for the same. The research aims to intervenewith the very fundamental aspects of drug prescription and its interaction inthe patient with a system of epileptic disorders.Onextraction of the required data (Total CK values of a seizure patient over acourse of time), I shall systematically plot it over a graph comparing itsquantity and time of exhibition.
The values collected involves the patient whois already diagnosed with at least one or two episodes of seizure. The valuescollected involve the assessment of patient’s prognosis over the anti-epilepticdrug used in order to manage the condition.Any work already done: -Very few studies in adult population have been conducted. To the best ofour knowledge, there have been no studies done which cumulatively focus theabove-mentioned objectives. Justificationand the Need to Study: -Epilepsy is the 4th most common neurological problem. In India more than 1 millioncases of epilepsy are recorded every year. Even though Creatine Kinase (CK) isevidently the most accessible parameter that can effectively help us learn moreabout seizures there has not been significant amount of research enabling us tounderstand the same.The current research focuses primarily in understandingthe relationship between Total CK and seizures and in turn assessing theintricate details of the same.
The agenda for the current research study hasbeen to effectively assess the role of Total CK in seizuresOBJECTIVESOF THE STUDY: -1.Tostudy the relationship between seizures and Total Creatine Kinase.2.Tostudy the effect of Phenytoin vs Levetiracetam on Total CK Level.3.
Toidentify and present the sequential changes in the values of Total CK duringthe course of treatment of a Seizure.Reviewof Literature: -· According to a study performed by Javaliet al, out of 100 patients subjected to study 36% of the patients presented with generalized tonic–clonicseizures (GTCS). The next common presentation was simple partial seizures(29%), complex partial seizures (CPS) (19%), and status epilepticus (SE) (7%)at admission. 9% of patients were retrospectively diagnosed to have PNES usingvideo-EEG.
Nearly 91.66% of patientswith GTCS who presented within 1 h had elevated CK whereas 70% of patients withpartial seizures had elevated CK. · In the review article of R.
D. Nass etal. it has been noted that CK starts rising during the first 1-12hours andpeaks after 24-72 hours in about 45% of GTCS. Creatine kinase (CK) elevationsare unlikely to occur in absence seizures but are found elevated inapproximately 35% of focal seizures.· Accordingto a Case Report presented by Isaacson et al, The case revealed a marked anddangerous increase in CK levelscorresponding with modest LEV use.Although this scenario could indicate a delayed rhabdomyolysis, the rapiddecline in CK with LEV discontinuation suggests that, in this patient, LEV mayhave had effects on kidney filtration and/or muscle breakdown. Discontinuationof LEV in patients with persisting CK elevations postconvulsive seizure should be considered.
Materials and Methods:· Studydesign: Prospective observationalstudy· Studyperiod:(i) Periodneeded for collecting data: 2 months(ii) Periodrequired for analyzing the data: 1 month· Inclusioncriteria: o Patientswith seizures who are admitted within 24 hours of the seizure event.o Patientswho have been treated with Levetiracetam or Phenytoin.o Patientsabove the age of 18 years.· Exclusioncriteria: o Patientsbelow the age of 18 yearso Patientsadmitted after 24 hours of seizure episodeo Pseudoseizure ( PNES )o Patientswho have received an IM injection o Patientswho have been treated with other Anti-Epileptic drugs apart from Levetiracetamand Phenytoin.o Patientswho have been admitted due to POLY TRAUMA.
· Sample Size with Proper Justification:o Sample size: 98· According to a study performed by Javaliet al (2017), out of 100 patients subjected to study 36% of the patients presented with generalized tonic–clonicseizures (GTCS). The next common presentation was simple partial seizures(29%), complex partial seizures (CPS) (19%), and status epilepticus (SE) (7%)at admission. 9% of patients were retrospectively diagnosed to have PNES usingvideo-EEG.
Nearly 91.66% of patients with GTCS who presented within 1 h hadelevated CK whereas 70% of patients with partial seizures had elevated Total CK. · In the present study expecting similarproportion; considering absolute precision of 8%; to achieve a desiredconfidence level of 95%; the sample size worked out to 98 epileptic patients. DetailedDescription of Procedure:-v Selectionof Subjects :- 98 Consecutive patientsbelonging to the inclusion criteria and admitted to Ramaiah Memorial Hospitalv Biochemicalestimate Required :- Total Creatine Kinase(CK) level.v Processof acquiring total CK ( Creatine Kinase ) level :-Reports of SerumCreatine Kinase (CK) done as a part of the standard patient management protocolin epilepsy (seizure) will be accessed and values will be recorded.Serum Creatine Kinase(CK) is done on Roche Cobas 6000 analyser by enzymatic colorimetric method inthe diagnostic laboratories in Ramaiah Memorial hospital.
v Numberof samples to be collected:- For every subjectincluded in the study a minimum of 3-4 consecutive serum total CK values willbe recorded till the post ictal phase is attained and the total CK level comesback to normal level. · Placeof Study: – Ramaiah Memorial Hospital· Investigations: – Total Creatine Kinase Level · Potential Risks and Benefits: -a. Theblood sample collected as a part of the routine investigations for Seizure(Epilepsy) would be used in this study.
Hence there is no introduction of anyadditional risks.b. Byconducting this study, we intend to provide scope for a further study onCreatine Kinase as it is clinically very important in the field of Diagnosisand Prognosis of Epilepsy. · Statistical Methods:-o Descriptive Statistics of values of Total Creatine Kinase(CK) will be analyzed and summarized in terms of percentage.o The values of Total Creatine Kinase (CK) in comparisonwith the time of exhibition will be analyzed and summarized in pictorialrepresentations using valid Graphs.o Chi-Squaretest would be used to compare Total Creatine Kinase (CK) normalization between different agegroups and sex.
· Ethical Considerations and Methods to Address Issues:- A written informed consent form would be provided to theparticipants. The participants will be informed about the procedure beforecollection of the Total Creatine Kinase ( CK ) values . · Implications of the study:-o Theresearch focusses on yielding a result that enables us to understand therelationship between Total Creatine Kinase (CK) level and Seizures.o Theresearch enables us to predict and prevent Drug Induced Seizures and in turnact as a precautionary entity.o The research aims to intervene with thevery fundamental aspects of drug prescription and its interaction in thepatient with a system of epileptic disorders . · Budget and proposed funding source:-NIL