FULL DETAILS (Read-only)

CTRI Number  CTRI/2010/091/000525 [Registered on: 25/11/2010]
Last Modified On: 23/02/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
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Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
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Effectiveness of early surgery over usual waiting list surgery (medical therapy) in Childhood Drug Refractory Epilepsy-(CDRE)  
Scientific Title of Study
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A Randomized controlled trial of early versus usual waitng list surgery in childhood intractable epilepsy 
Secondary IDs if Any
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Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name  Manjari Tripathi 
Address  Room No-705, 7th Floor,C.N.C. AIIMS

New Delhi
DELHI
110029
India 
Phone  011-26594494  
Fax    
Email  manjari.tripathi@gmail.com  
 
Details Contact Person
Scientific Query

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Name  Dr Manjari Tripathi  
Address  Room No-705,7th Floor, CNC,AIIMS

New Delhi
DELHI
110029
India 
Phone  011-26594494  
Fax    
Email  manjari.tripathi@gmail.com  
 
Details Contact Person
Public Query

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Name  Rekha Dwivedi 
Address  Room No-705,Dept of Neurology
7th Floor,CNC,AIIMS
New Delhi
DELHI
110029
India 
Phone  011-26594494  
Fax    
Email  rekha.dwivedi2006@gmail.com  
 
Source of Monetary or Material Support
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All India Institute of Medical Sciences (AIIMS) 
 
Primary Sponsor
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Name  All India Institute of Medical Sciences AIIMS 
Address  Ansari Nagar New Delhi INDIA PIN CODE 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor
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Name  Address 
NIL   
 
Countries of Recruitment
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  India  
Sites of Study
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No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
DrManjari Tripathi  AIIMS  Ansari Nagar,AIIMS-110029
New Delhi
 
011-26594494

manjari.tripathi@gmail.com 
 
Details of Ethics Committee
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No of Ethics Committees= 4  
Name of Committee  Approval Status 
AIIMS  Approved 
All India Institute of Medical Sciences   Approved 
Data Safety Management Board  Approved 
DSMB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
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Health Type  Condition 
Patients  Childhood Intractable Epilepsy 
 
Intervention / Comparator Agent
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Type  Name  Details 
Intervention  Early Epilepsy surgery  After randomization subject will be enrolled within one month 
Comparator Agent  usual waiting list epilepsy surgery or Medical therapy  Subject will be enrolled as per the usual waiting list of surgery (medical therapy till dated surgery) that may be one year or so. 
 
Inclusion Criteria
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Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1) All children with DRE patients: age ≤18 years.

2) Patients having DRE, defined as failure of adequate trials of two tolerated and appropriately chosen and used anti-epileptic drug schedules for years to achieve sustained seizure freedom.

3)All patients should have been cleared by the Unit III-epilepsy surgery-case conferences team.

4)All parents of patients or Legally Acceptable Representative (LAR)should be able to give Consent for participation. 
 
ExclusionCriteria 
Details  1) All patients who have underlying metabolic abnormality, cardiac abnormality, renal failure and respiratory disease.

2) Those patients having Status Epilepticus requiring early or immediate surgery(as these are not put in wait list).

 
 
Method of Generating Random Sequence
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Computer generated randomization 
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
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Outcome Assessor Blinded 
Primary Outcome
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Outcome  TimePoints 
The primary outcome will be to assess the seizure freedom between the two groups by International League Against Epilepsy (ILAE) Scale or Engels Scale at 12 months  Baseline, Six months and one year follow-up.  
 
Secondary Outcome
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Outcome  TimePoints 
To assess the differences in the occurrence of seizures over a period of 12 months, and seizure-severity, cognition, behavior and quality of life by the following measures: the Hague seizure Severity (HASS) scale, Binet Kamat Test (BKT ) and Vineland Social Maturity Scale (VSMS), Child Behavior Check List (CBCL) ,Pediatrics Quality of Life (PedsQL), respectively.  Baseline,Six months and One year follow-up 
 
Target Sample Size
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Total Sample Size="116"
Sample Size from India="116" 
Phase of Trial
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Phase 3 
Date of First Enrollment (India)
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01/11/2010 
Date of First Enrollment (Global)  01/11/2010 
Estimated Duration of Trial
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Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
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Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
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under revision 
Brief Summary
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This study is a randomized controlled trial to assess the efficacy of the early epilepsy surgery over usual-dated  epilepsy surgery (with continued medical therapy) in surgically remediable childhood drug refractory epilepsy. It is being conducted in All India Institute of medical Sciences (AIIMS), New Delhi. The primary objective of this study is to assess the outcome of seizures in the epilepsy surgery (Intervention group) versus the usual waiting list surgery with medical therapy (non-intervention group) at 12 months.The secondary objective of the study is  to evaluate seizure severity, cognition, behavior and quality of life through clinical and neuro-psychological assessment  by  the Hague Seizure Severity (HASS) scale, Binet Kamat Test (BKT),Vineland Social Maturity Scale (VSMS), Child Behavior Check List (CBCL) and Pediatrics Quality of Life (PedsQL), respectively between the two groups . 

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