| 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
|
|
|
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
|
|
|
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. |