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INTRODUCTION:

A seizure represents the clinical expression of
abnormal, excessive, synchronous discharges of neurons residing primarily in
cerebral cortex. Epilepsy considered to be a disease of the brain defined by
any 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 recurrence
risk (at least 60%) after two unprovoked seizures, occurring over the next 10
years;                                                             (3) diagnosis of an epilepsy
syndrome.

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Creatine
Kinase has been a standard investigating parameter in the field of seizures (Epilepsy).
The current research focuses primarily in understanding the relationship
between Total CK and seizures and in turn assessing the intricate details of
the same. The agenda for the current research study has been to effectively
assess the role of Total CK in seizures and in turn evaluate the pharmacological
effects of various anti-epileptic drugs used in order to manage the medical
condition of seizures. As CK is also a direct indicator of extent of
rhabdomyolysis the study aims to predict and prevent acute renal failure and in
turn act as a precautionary entity for the same. The research aims to intervene
with the very fundamental aspects of drug prescription and its interaction in
the patient with a system of epileptic disorders.

On
extraction of the required data (Total CK values of a seizure patient over a
course of time), I shall systematically plot it over a graph comparing its
quantity and time of exhibition. The values collected involves the patient who
is already diagnosed with at least one or two episodes of seizure. The values
collected involve the assessment of patient’s prognosis over the anti-epileptic
drug used in order to manage the condition.

Any work already done: –

Very few studies in adult population have been conducted. To the best of
our knowledge, there have been no studies done which cumulatively focus the
above-mentioned objectives.

 

 

 

Justification
and the Need to Study: –

Epilepsy is the 4th most common neurological problem. In India more than 1 million
cases of epilepsy are recorded every year. Even though Creatine Kinase (CK) is
evidently the most accessible parameter that can effectively help us learn more
about seizures there has not been significant amount of research enabling us to
understand the same.

The current research focuses primarily in understanding
the relationship between Total CK and seizures and in turn assessing the
intricate details of the same. The agenda for the current research study has
been to effectively assess the role of Total CK in seizures

OBJECTIVES
OF THE STUDY: –

1.To
study the relationship between seizures and Total Creatine Kinase.

2.To
study the effect of Phenytoin vs Levetiracetam on Total CK Level.

3.To
identify and present the sequential changes in the values of Total CK during
the course of treatment of a Seizure.

Review
of Literature: –

·       
According to a study performed by Javali
et al, out of 100 patients subjected to study 36% of the patients presented with generalized tonic–clonic
seizures (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 using
video-EEG. Nearly 91.66% of patients
with GTCS who presented within 1 h had elevated CK whereas 70% of patients with
partial seizures had elevated CK.

 

·       
In the review article of R.D. Nass et
al. it has been noted that CK starts rising during the first 1-12hours and
peaks after 24-72 hours in about 45% of GTCS. Creatine kinase (CK) elevations
are unlikely to occur in absence seizures but are found elevated in
approximately 35% of focal seizures.

·       
According
to a Case Report presented by Isaacson et al, The case revealed a marked and
dangerous increase in CK levels

corresponding with modest LEV use.
Although this scenario could indicate a delayed rhabdomyolysis, the rapid
decline in CK with LEV discontinuation suggests that, in this patient, LEV may
have had effects on kidney filtration and/or muscle breakdown. Discontinuation
of LEV in patients with persisting CK  elevations post
convulsive seizure should be considered.

 

Materials and Methods:

·       
Study
design: Prospective observational
study

·       
Study
period:

(i)               
Period
needed for collecting data: 2 months

(ii)            
Period
required for analyzing the data: 1 month

·       
Inclusion
criteria:

o  
Patients
with seizures who are admitted within 24 hours of the seizure event.

o  
Patients
who have been treated with Levetiracetam or Phenytoin.

o  
Patients
above the age of 18 years.

·       
Exclusion
criteria:

o  
Patients
below the age of 18 years

o  
Patients
admitted after 24 hours of seizure episode

o  
Pseudo
seizure ( PNES )

o  
Patients
who have received an IM injection

o  
Patients
who have been treated with other Anti-Epileptic drugs apart from Levetiracetam
and Phenytoin.

o  
Patients
who have been admitted due to POLY TRAUMA.

 

 

·       
Sample Size with Proper Justification:

o  
      Sample size: 98

·       
According to a study performed by Javali
et al (2017), out of 100 patients subjected to study 36% of the patients presented with generalized tonic–clonic
seizures (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 using
video-EEG. Nearly 91.66% of patients with GTCS who presented within 1 h had
elevated CK whereas 70% of patients with partial seizures had elevated Total CK.

 

·       
In the present study expecting similar
proportion; considering absolute precision of 8%; to achieve a desired
confidence level of 95%; the sample size worked out to 98 epileptic patients.

 

Detailed
Description of Procedure:-

v Selection
of Subjects :-

 98 Consecutive patients
belonging to the inclusion criteria and admitted to Ramaiah Memorial Hospital

v Biochemical
estimate Required :-

Total Creatine Kinase
(CK) level.

v Process
of acquiring total CK ( Creatine Kinase ) level :-

Reports of Serum
Creatine Kinase (CK) done as a part of the standard patient management protocol
in 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 in
the diagnostic laboratories in Ramaiah Memorial hospital.

 

v Number
of samples to be collected:-

For every subject
included in the study a minimum of 3-4 consecutive serum total CK values will
be recorded till the post ictal phase is attained and the total CK level comes
back to normal level.

 

·     
Place
of Study: – Ramaiah Memorial Hospital

·      Investigations: – Total Creatine Kinase Level

 

·     
Potential Risks and Benefits: –

a.    
The
blood sample collected as a part of the routine investigations for Seizure
(Epilepsy) would be used in this study. Hence there is no introduction of any
additional risks.

b.    
By
conducting this study, we intend to provide scope for a further study on
Creatine Kinase as it is clinically very important in the field of Diagnosis
and 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 comparison
with the time of exhibition will be analyzed and summarized in pictorial
representations using valid Graphs.

o  
Chi-Square
test would be used to compare Total Creatine Kinase (CK) normalization between different age
groups and sex.

 

 

·       
Ethical Considerations and Methods to Address Issues:-

 A written informed consent form would be provided to the
participants. The participants will be informed about the procedure before
collection of the Total Creatine Kinase ( CK ) values .

 

·      Implications of the study:-

o  
The
research focusses on yielding a result that enables us to understand the
relationship between Total Creatine Kinase (CK) level and Seizures.

o  
The
research enables us to predict and prevent Drug Induced Seizures and in turn
act as a precautionary entity.

o  
The research aims to intervene with the
very fundamental aspects of drug prescription and its interaction in the
patient with a system of epileptic disorders .

 

·      Budget and proposed funding source:-
NIL

 

 

REFERENCES:-

 

1.     Mahendra
Javali, Purushottam
Acharya, Shripal
Shah. Role of
Biomarkers in Differentiating New-onset Seizures from Psychogenic Nonepileptic
Seizures .J Neurosci Rural Pract. 2017 Oct-Dec;8(4):581-584.doi:10.4103/jnrp.jnrp_139_17.

 

2.     Julia
E. Isaacson , Dongwhoon J. Choe , Michael J. Doherty. Creatine Kinase elevation
exacerbated by levetiracetam therapy. Epilepsy and Behaviour case reports 2(2014)
18 9-191

 

3.     Christoph
Kurth, Edgar Kockelmann,Bernhard J. Steinhoff. Clinical outcomes of perampanel
vs. lacosamide in cohorts of consecutive patients with severely refractory
epilepsies — A monocentric retrospective analysis of systematically collected
data from the German Kork Epilepsy Center. Seizure 45 (2017) 47-51.

 

4.    
Wyllie E, Lueders H, Pippenger C, VanLente F. Postictal Serum Creatine Kinase in the diagnosis of seizure
disorders.  Arch Neurol. 1985 Feb;42(2):123-6.

 

5.    
Brigo F, Igwe SC, Erro R.
Postictal Serum Creatine Kinase for the differential diagnosis of epileptic
seizures and psychogenic non epileptic seizures ; a systematic review. J Neurol. 2015 Feb;262(2):251-7. doi: 10.1007/s00415-014-7369-9.
Epub 2014 May 14.

 

6.    
Glötzner FL, Planner M, Gaab M.
Creatine Kinase in serum after Grand Mal Seizures. Eur Neurol. 1979;18(6):399-404.

 

7.    
Marvin M. Goldenberg. Overview of Drugs used for Epilepsy and
Seizures. P T. 2010 Jul; 35(7): 392–415.

 

8.     Martin J. Brodie, Frank Besag, Alan B. Ettinger.Epilepsy,Anti-Epileptic Drugs and Aggression : An evidence
based Review. Pharmacol Rev. 2016
Jul; 68(3): 563–602.

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