Health Condition 1: null- Childhood Intractable Epilepsy Health Condition 2: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Early Epilepsy surgery: After randomization subject will be enrolled within one month
Control Intervention1: usual waiting list epilepsy surgery or Medical therapy: Subject will be enr
Sponsors
All India Institute of Medical Sciences AIIMS
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactRekha Dwivedi
Dept of Neurology
Outcome results
None listed