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CTRI Number  CTRI/2024/12/078344 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Long term prospective study on seizure outcomes following epilepsy surgery 
Scientific Title of Study   Long term prospective correlative cohort study on outcomes from epilepsy surgery.  
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 Ashok Pillai 
Designation  Clinical professor and Neurosurgeon 
Affiliation  Amrita Institute of medical sciences and research centre 
Address  Department of neurosurgery Amrita Institute of medical sciences and research centre Ponekkara Road P O Edappally Kochi

Ernakulam
KERALA
682041
India 
Phone  7034028231  
Fax    
Email  brashok@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Pillai 
Designation  Clinical professor and Neurosurgeon 
Affiliation  Amrita Institute of medical sciences and research centre 
Address  Department of neurosurgery Amrita Institute of medical sciences and research centre Ponekkara Road P O Edappally Kochi

Ernakulam
KERALA
682041
India 
Phone  7034028231  
Fax    
Email  brashok@aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Pillai 
Designation  Clinical professor and Neurosurgeon 
Affiliation  Amrita Institute of medical sciences and research centre 
Address  Department of neurosurgery Amrita Institute of medical sciences and research centre Ponekkara Road P O Edappally Kochi

Ernakulam
KERALA
682041
India 
Phone  7034028231  
Fax    
Email  brashok@aims.amrita.edu  
 
Source of Monetary or Material Support  
Amrita Institute of medical sciences and research centre Ponekkara P o Kochi Ernakulam 682041 India 
 
Primary Sponsor  
Name  None 
Address  NONE 
Type of Sponsor  Other [ Prospective study conducted in Amrita Advanced Centre for Epilepsy in Amrita Hospital Kochi] 
 
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 
DrAshok Pillai  Amrita Institute of medical sciences  Amrita Institute of medical sciences and research centre,Ponekkara Road, P O Edappally Kochi Ernakulam,Kerala 682041
Ernakulam
KERALA 		 07034028231

brashok@aims.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EthicsCommitteeofAmritaschoolofMedicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, (3) ICD-10 Condition: G402||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, (4) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, (5) ICD-10 Condition: G40B||Juvenile myoclonic epilepsy [impulsive petit mal], (6) ICD-10 Condition: G408||Other epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  80.00 Year(s)
Gender  Both 
Details  •All patients with pharmaco-resistant epilepsy
who undergo epilepsy surgery as
determined by the multidisciplinary pre-surgical epilepsy patient management conference ( PMC).
• Patients who are interested to
participate in the study. 
 
ExclusionCriteria 
Details  Patients who are already controlled with
anticonvulsant drug treatment.
• Participants who are not willing to sign the
informed consent document. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
seizure outcome
 		 3 ,6 and 12 months and yearly follow up- up to 5 years
 
 
Secondary Outcome  
Outcome  TimePoints 
1. correlation of seizure outcome with individual imaging modalities
2. correlation of seizure outcome with image post-processing analysis
3. correlation of seizure outcome with pathology
4. quality of life assessment using standardized scales (QOLIE 31, etc.)  		 3 ,6 and 12 months and yearly follow up- up to 5 years
 
 
Target Sample Size
Modification(s)  		 Total Sample Size="400"
Sample Size from India="400" 
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)   02/01/2025 
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="5"
Months="11"
Days="28" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This prospective cohort study will be conducted at the Department of Department of Amrita Advanced centre for Epilepsy (AACE). It will include all pharmaco-resistant epilepsy patients who will undergo refractive surgery as determined by the pre-surgical epilepsy conference. Data will be collected after obtaining the informed consed form. Data collected will encompass demographic and clinical information obtained directly from patient interviews, as well as electrophysiological, imaging, and post-processing data acquired from the PEC meeting. This data will be recorded directly in the EDC system. The entered data will be verified and validated by the PI or the PI’s designee according to the data management plan. The cleaned data will then be statistically analyzed and utilized for publications in future. 
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