| CTRI Number |
CTRI/2025/12/099685 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Clinical, EEG, and MRI Features of Afebrile Focal Seizures in Children |
|
Scientific Title of Study
|
A study of clinical profile, electroencephalographic (EEG) characteristics and magnetic resonance imaging (MRI) findings of afebrile focal seizures in children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anagha Srikanth |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics, Kasturba Medical College, Madhavnagar, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
9113665040 |
| Fax |
|
| Email |
anagahsrikanth2599@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ramesh Bhat Y |
| Designation |
Professor and Head of Department of Paediatrics. |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics, Kasturba Medical College, Madhavnagar, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
9686401313 |
| Fax |
|
| Email |
docrameshbhat@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Anagha Srikanth |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics, Kasturba Medical College, Madhavnagar, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
9113665040 |
| Fax |
|
| Email |
anagahsrikanth2599@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ramesh Bhat Y |
| Address |
Kasturba Medical College
Madhav nagar, Manipal,
Udupi district, Karnataka, India.
PIN code 576104
|
| 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 Anagha Srikanth |
Kasturba Medical College and Hospital |
Department of Paediatrics, Kasturba Medical College and Hospital, Manipal Udupi KARNATAKA |
9113665040
anaghasrikanth2599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, (2) ICD-10 Condition: G402||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, (3) ICD-10 Condition: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 18 years with afebrile focal seizures |
|
| ExclusionCriteria |
| Details |
1. Children with afebrile focal seizures in whom imaging could not be obtained.
2. Children with afebrile focal seizures following head injury, nuerosurgery or RTA. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to study and analyse the clinical profile, electroencephalographic (EEG) characteristics and magnetic resonance imaging (MRI) findings of afebrile focal seizures in children. |
At baseline, primary visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
02/01/2026 |
| 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="1" Months="6" Days="1" |
|
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
|
Focal seizures (previously known as partial seizures) are caused by electrical discharges that originate in one hemisphere of the brain and cause symptoms based on the neuronal area they affect. There are two subtypes of focal seizure, categorized based on whether or not the seizures affect consciousness. Focal aware seizure (previously simple partial seizure) and Focal impaired awareness seizure (previously complex partial seizure).
Early and accurate diagnosis of focal seizures in children is crucial, as it directly influences treatment decisions, prognosis, and quality of life. A detailed clinical history, electroencephalography (EEG), and neuroimaging—particularly magnetic resonance imaging (MRI) of brain help in further diagnosis.
By systematically analyzing the clinical profile, EEG characteristics, and MRI findings in children with focal seizures, this study aims to better understand diagnostic consistency and support evidence-based approaches to management. It will also help identify patterns of presentation that can prompt early investigation, improve prognosis, and potentially reduce the burden of uncontrolled epilepsy in children. |