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CTRI Number  CTRI/2025/09/095432 [Registered on: 26/09/2025] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   An observational study to Assess the Use of Blood Markers Prolactin and Creatine Phosphokinase levels in Distinguishing Epileptic Seizures from Non-Epileptic Events 
Scientific Title of Study   Evaluating Serum Prolactin and Creatine Phosphokinase as Differential Biomarkers in Epileptic Versus Psychogenic Non-Epileptic Seizures 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Roshan M 
Designation  Post Graduate Student 
Affiliation  Yenepoya School of Allied Health Sciences 
Address  Department of Neurology Yenepoya School of Allied Health Sciences Yenepoya (deemed to be University) Deralakatte Mangalore Dakshina Kannada Karnataka 575018
Deralakatte Mangalore Dakshina Kannada Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9663332927  
Fax    
Email  roshanm3127@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Salma Suhana 
Designation  Associate Professor 
Affiliation  Yenepoya Medical college Hospital  
Address  Department of Neurology Yenepoya medical college hospital (deemed to be University) Deralakatte Mangalore Dakshina Kannada Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9741967190  
Fax    
Email  suhanas18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Salma Suhana 
Designation  Associate Professor 
Affiliation  Yenepoya Medical college Hospital 
Address  Department of Neurology Yenepoya medical college hospital (deemed to be University) Deralakatte Mangalore Dakshina Kannada Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9741967190  
Fax    
Email  suhanas18@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Medical college yenepoya (deemed to be university) Deralakatte Mangalore Dakshina Kannada karnataka India 575018 
 
Primary Sponsor  
Name  Roshan M 
Address  Yenepoya School of Allied Health ScienceS mudipu campus near surya tech park kayargoli kurnad post bantwal 574153 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Salma Suhana  Yenepoya Medical college hospital  Department of Neurology in EEG lab 5th floor Deralakatte Mangalore 575018 Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA 
09741967190

suhanas18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
yenepoya ethics committee 4  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with Epileptic seizures and psychogenic non epileptic seizures above 18 years of age  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with confirmed Epileptic Seizures aged above 18 years based on clinical history and video-EEG findings.
Patients with confirmed Psychogenic Non-Epileptic Seizures aged above 18 years based on video-EEG and absence of epileptiform activity.
 
 
ExclusionCriteria 
Details  Presence of other neurological disorders where CPK is elevated.
History of substance abuse.
Post-traumatic injury associated with Intracranial meningioma, Lactate dehydrogenase, and pregnancy due to increased prolactin.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare serum Prolactin levels in patients diagnosed with Epileptic Seizures and patients diagnosed with Psychogenic Non-Epileptic Seizures following a witnessed event.  To assess and compare serum Prolactin levels in patients diagnosed with Epileptic Seizures and patients diagnosed with Psychogenic Non-Epileptic Seizures following a witnessed event. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the potential for a combined analysis of Prolactin & Creatine Phosphokinase levels to improve the accuracy of differentiating Epileptic Seizures from Psychogenic Non-Epileptic Seizures compared to either biomarker  To compare prolactin & CPK levels after seizure within 30 minutes occurrence 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title: Evaluating the role of Prolactin and Creatine-Phosphokinase as biomarkers for differentiating Epileptic seizures from Psychogenic Non-Epileptic seizures – A Prospective Study

Accurately distinguishing Epileptic Seizures from Psychogenic Non-Epileptic Seizures is crucial for proper treatment. Seizures are caused by abnormal neuronal activity in the brain, while epilepsy refers to recurrent seizures due to an underlying chronic condition. In contrast, PNES are non-epileptic, emotionally triggered events that often resemble Epileptic seizures, making diagnosis challenging. PNES can occur in both epileptic and non-epileptic patients and is commonly linked to psychological conditions like somatoform disorders. The gold standard for diagnosing epilepsy is a positive EEG, though a negative EEG does not exclude the diagnosis. In settings where video-EEG is unavailable, there is a pressing need for more accessible diagnostic tools. Misdiagnosis can lead to unnecessary treatment with antiepileptic drugs, which can have significant side effects. Therefore, alternative diagnostic methods are needed. This study explores the potential of serum Prolactin and Creatine Phosphokinase as biomarkers to differentiate between Epileptic Seizures and Psychogenic Non-Epileptic Seizures. Elevated Prolactin levels are often seen in Epileptic Seizures, especially Generalized Tonic-Clonic Seizures. At the same time, Creatine Phosphokinase levels may also be higher in Epileptic Seizures due to muscle injury during convulsions. In this study, inpatients and outpatients with a history of Epileptic Seizures and Psychogenic Non-Epileptic Seizures will be referred for Prolactin and Creatine Phosphokinase testing within 1 hour of seizure onset. The results will be analyzed to determine whether Prolactin and Creatine Phosphokinase levels can reliably differentiate between Epileptic and Non-Epileptic Seizures, particularly in settings with limited access to advanced diagnostic tools like video-EEG. Findings could improve the accuracy of seizure diagnoses and help prevent unnecessary treatments.

 
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