Effectiveness of early surgery over usual waiting list surgery (medical therapy) in Childhood Drug Refractory Epilepsy-(CDRE)
Phase 3
Completed
- Conditions
- Health Condition 1: null- Childhood Intractable EpilepsyHealth Condition 2: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2010/091/000525
- Lead Sponsor
- All India Institute of Medical Sciences AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
Inclusion Criteria
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.
Exclusion Criteria
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 monthsTimepoint: Baseline, Six months and one year follow-up.
- Secondary Outcome Measures
Name Time Method 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.Timepoint: Baseline,Six months and One year follow-up